Introduction

Early commitments by world leaders to global solidarity in responding to COVID-19 quickly broke down as wealthy countries bought up and hoarded health technologies for COVID-19 and corporate entities asserted their monopoly power to fully capitalise on the pandemic and prevent expanded manufacturing of health technologies in short supply by ‘competitor’ companies.

The nationalist approach taken by wealthy countries, and profiteering off the pandemic by corporate interests, has resulted in health technology Apartheid – where wealthy countries have at times held surplus supplies of health technologies needed to manage COVID-19, while poor countries have gotten ‘the scraps’.

Global inequity in the world’s response to COVID-19 emerged early on as countries scrambled to secure available supplies of diagnostics and personal protective equipment (PPE) and wealthy countries used their political and economic might to corner supply.[1][2] Across Africa, available diagnostic machinery to rapidly scale-up COVID-19 diagnosis sat unused as diagnostic companies prioritised delivery of test materials to wealthy countries.[3] In South Africa, access challenges for quality PPE required to protect frontline health care workers were severely exacerbated by corruption in the procurement processes, which resulted in the procurement of substandard products.[4]

In the vaccine space, wealthy countries pre-bought supplies of vaccines under development in far greater quantities than even needed for their own populations to ensure they would be first in line to receive vaccines against COVID-19, while many poor countries not in the economic position to pre-buy vaccine supplies at-risk turned to COVAX to secure supply. [5] Yet, once vaccines were approved for use, large pharmaceutical companies prioritised delivery of orders to wealthy countries over COVAX and poor countries – while, in some cases, even ignoring requests to place orders for vaccine supplies from poor countries.[6]

South Africa has for the most part procured COVID-19 vaccines through bilateral deals with companies. In securing vaccine supplies, the country has pushed back against requests from pharmaceutical companies to indemnify the companies against lawsuit by putting up sovereign assets as collateral and dealt with delayed delivery of supplies.[7][8]  While the country is now grappling with high rates of vaccine hesitancy, it has managed to administer over 30 million vaccine doses since administering the first vaccine to a frontline nurse in February 2021.[9][10]

While much work remains to be done to increase South Africa’s vaccination rates – including dealing with high rates of vaccine hesitancy and ensuring access for hard-to-reach populations and undocumented migrants – as of 10 February 2021, over 40% of South Africa’s adult population has been fully vaccinated against COVID-19 (receiving one J&J or two Pfizer doses).[11]

Despite these important advancements, building and ensuring security of health technology supply is critical to improving vaccine access across the continent and ensuring people in South Africa and the region are protected from both ongoing health threats related to COVID-19, neglected diseases common on the continent for which too few health technologies exist, and future pandemic threats.

Since Covid’s emergence, Pres. Cyril Ramaphosa has repeatedly highlighted the need to build health technology manufacturing capacity, and particularly vaccine manufacturing capacity, on the continent to protect the health of Africans and prevent the continuation and repetition of the health technology Apartheid seen during the COVID-19 pandemic.[12]

To tackle the immediate challenge of COVID-19 health technology supply shortages, South Africa has together with India proposed the adoption of a ‘TRIPS Waiver’ at the World Trade Organisation to allow countries to not grant or enforce intellectual property protections throughout the pandemic. The waiver, which has not been granted due to ongoing opposition by a group of wealthy countries, could allow for the full realisation of available manufacturing capacity globally in combatting COVID-19 – rather than leaving control over manufacturing decisions with private companies that prioritise profit making over achieving global access. Johnson & Johnson, for example, recently halted production of its critically needed COVID-19 vaccines, in order to manufacture a potentially more profitable vaccine for clinical trials related a different health condition.[13]

Yet, while South Africa has championed the TRIPS waiver globally, it has failed to undertake long delayed pro-public health reform of its domestic patent laws, which would put the country in a stronger position to combat monopoly power abuse at a national level and advocate for reform at a global level.

Overview

This analysis explores how patents and other intellectual property protections have affected registering, purchasing, importing, use and/or local manufacturing of COVID-19 health technologies. The health technologies explored as case studies in this analysis to understand how patents and other forms of intellectual property impact access to, and local manufacturing of, COVID-19 health technologies are:

  • Vaccines: Moderna and Pfizer’s mRNA vaccines
  • Diagnostics: Cepheid’s COVID-19 diagnostic cartridges
  • Therapeutics: molnupiravir and ritonavir-boosted nirmatrelvir

This analysis also explores how South Africa—and civil society within the country—have sought to overcome patent barriers on COVID-19 health technologies and the successes and weaknesses of these strategies.

Data was sourced for this analysis through an extensive review of grey literature, attendance of relevant webinars, in-depth interviews, and sourcing stakeholder input through email and phone communication. Six in-depth interviews were conducted with key informants with expertise on civil society advocacy, intellectual property, regulatory procedures, manufacturing capacity, and health systems application of COVID-19 health technologies in South Africa. One interviewee requested to be quoted anonymously and is referred to in the report as Interviewee 3.

Findings

Our analysis found that patents and other forms of intellectual property protection (i.e., trade secrets and withholding of knowledge) have posed a significant barrier to COVID-19 health technology access and local manufacturing during the pandemic, which has played a role in worsening pre-existing gender inequities in the country. Where licensing arrangements and technology transfer have been committed to by intellectual property holders, this has created a legal pathway for the introduction of competitor products that can expand supply and improve affordability. However, licensing and technology transfer arrangements to enable local manufacturing and/or ‘generic’ access in South Africa have been rare during the pandemic. While South Africa has played an important role in building global awareness of how patents and other intellectual property protections impede access to, and expanded manufacturing of, COVID-9 health technologies by championing the TRIPS waiver request, it has failed to address monopoly abuse by patent holders at a national level or undertake necessary domestic legislative reform.

Key findings:

Moderna:

  • Despite committing to not assert patents on its COVID-19 vaccine during the pandemic, Moderna has filed multiple patents related to its COVID-19 vaccine in South Africa and refused to cooperate with the efforts of the WHO mRNA Technology Transfer Hub based at Afrigen in Cape Town, South Africa
  • The lack of a licensing and technology transfer arrangement with Moderna poses a legal barrier to commercialisation (by a commercial partner of the Hub) of the mRNA COVID-19 vaccine currently under development by the WHO mRNA Hub. The Hub is currently utilising Moderna’s pledge not to assert its patents during the pandemic – which the company may select to end at any time – and the Bolar exception provided for in South Africa’s patent laws and under TRIPS as a legal pathway to advance vaccine development. Afrigen has successfully made a laboratory scale batch of an mRNA COVID-19 vaccine and is seeking regulatory approvals and building capacity to develop a clinical trial sized batches.
  • In addition to creating significant uncertainty for the prospects of commercialising vaccines developed by the WHO mRNA Hub, the refusal of Moderna to license its intellectual property and transfer its technology will significantly slow down efforts of the WHO mRNA Hub to expand supply of COVID-19 mRNA vaccines for use in underserved, developing nations. The lack of licensing and technology transfer arrangements from Moderna will require the WHO mRNA Hub to undertake more extensive and time-consuming clinical trials on its vaccine candidate, develop its own quality control and operating procedures required for regulatory approval, and may result in expensive and time-consuming litigation with Moderna that delays commercialisation of its vaccine.

Civil society recommendations:

  • Ramp up pressure on Moderna to license its intellectual property and transfer its technology to the WHO mRNA Tech Transfer Hub.
  • Develop an advocacy and legal strategy to challenge patents granted to Moderna in South Africa.
  • Continue to advocate for urgent reform of South Africa’s patent laws to ease the process of compulsory licensing to protect public interest in the country.

Pfizer (vaccine):

  • Between 2003 and 2020, 14 patents (3 of which were withdrawn) related to the Pfizer/BioNTech COVID-19 mRNA vaccine were filed through WIPO’s Patent Cooperation Treaty (PCT).[14] None of these patents were filed in South Africa, however during 2021, an additional two patent applications on the Pfizer/BioNTech vaccine were filed through WIPO’s PCT (WO2021213924 A1, WO 2021/213945 A1).[15] Pfizer/BioNTech have until 22 October 2022 to file these applications in South Africa. However, given that South Africa does not have a patent opposition procedure, or a process for sharing the details of new patent applications publicly, it will be difficult for civil society to monitor whether these applications are filed in the country.
  • While Pfizer has given a fill-and-finish license to Biovac to enable the company to produce vials of vaccines with imported drug substance it has not given any licenses or transferred technology to enable production of its COVID-19 mRNA vaccine’s drug substance in Africa and it has refused to cooperate with the WHO mRNA Hub. At the same time, Pfizer’s CEO has openly opposed the adoption of a WTO TRIPS waiver that could facilitate manufacture of its vaccine by competitor companies.

Civil society recommendations:

  • Ramp up pressure on Pfizer to license its intellectual property and transfer its technology to the mRNA Hub, and/or through the Medicines Patent Pool or the COVID-19 Technology Access Pool (CTAP).
  • Engage relevant officials and departments within the South African government (CIPC, DTI, DSI) on the critical need to monitor new patent applications related to Pfizer’s vaccine and to ensure that patents that do not meet the country’s patentability criteria or harm public health/interest are not granted.
  • Continue to advocate for urgent reform of South Africa’s patent laws to strengthen the country’s patentability criteria, protect public interest, and enable opposition of patent applications by third parties.

Cepheid:

  • During early stages of the pandemic, shortages of Cepheid’s COVID-19 test cartridges severely hampered South Africa’s ability to rapidly scale-up COVID-19 diagnosis. Despite being the first country to nationally roll-out Cepheid’s diagnostic platforms and a crucial site for the company’s trialling of the machines, Cepheid prioritised delivery of diagnostic test cartridges to wealthy countries over developing ones, including South Africa. While failing to deliver adequate supply of test cartridges, Cepheid ignored requests from South Africa for technology transfer to enable local manufacturing of its test cartridges.
  • Cepheid has used a variety of tactics to build its monopoly position in the diagnostic space and undermine the entry/growth of competitor companies, including designing systems that prevent the use of test materials made by other companies, hoarding knowledge and refusing to license IP and transfer technology, and filing patents.

Civil society recommendations:

  • Push Cepheid to license its intellectual property and transfer technology to diagnostic manufacturers in developing countries.
  • Engage global stakeholders and conduct further research on the need for and feasibility of financing and developing open-diagnostic systems that provide ease of use (automated), can rapidly conduct diagnosis of multiple specimens, and can be used at or near point-of-care.
  • Engage national stakeholders on what is needed to develop national diagnostic manufacturing capacity and ensure that capacity developed is sustainable.

Merck (medicine):

  • Two patents related to Merck’s (MSD’s) antiviral molunpiravir which is used for treatment of COVID-19 have been filed in South Africa (ZA201704291 and ZA202002849), lasting through 2035 and 2038, respectively.[16] However, Merck has granted a license enabling generic manufacture of molnupiravir through the Medicine Patent Pool (MPP). Two South African companies, Aspen Pharmacare and CPT Pharma, have been licensed by the MPP to manufacture generic molnupiravir. However, the MPP license only allows for the sale of generic products produced under the deal in South Africa’s public health sector (and in other developing countries included in the licensing deal). The exclusion of South Africa’s private sector from the MPP deal will require private users to procure the originator medicine from MSD – likely at a far higher cost than available generics. The exclusion of South Africa’s private health sector from the MPP deal, may also disincentivise production of the medicine by licensed local companies.

Civil society recommendations:

  • Support compulsory licensing efforts in developing countries excluded from the MPP deal.
  • Push Merck (MSD) to license the sale of generic molnupiravir in South Africa’s private sector – potentially through bilateral deals with Aspen Pharmacare and CPT Pharma.
  • Push Merck to license companies to sell generic molnupiravir in developing countries excluded from the MPP licensing deal.

Pfizer (medicine):

  • Pfizer has filed a patent on its antiviral medicine ritonavir-boosted nirmatrelvir in South Africa, lasting through 2041 (ZA-PCT/IB2021/057281).[17] However, Pfizer has licensed its intellectual property through a licensing deal with the MPP. Under the deal, licensed generic manufacturers will be able to sell generic ritonavir-boosted nirmatrelvir in specified jurisdictions, including in South Africa’s public sector. However, as South Africa’s private sector is excluded from the deal, private sector users will be required to procure ritonavir-boosted nirmatrelvir directly from Pfizer – likely at a far higher price than available generics.

Civil society recommendations:

  • Push Pfizer to license the sale of generic ritonavir-boosted nirmatrelvir in South Africa’s private sector.

Government’s response to COVID-19 in South Africa: “a mixed-bag”

South Africa detected its first case of COVID-19 on 5 March 2020. Ten days later, President Cyril Ramaphosa declared a national state of disaster as provided for under the Disaster Management Act and announced measures that the country would take to combat COVID-19, including the use of lockdowns to combat its spread.[18][19]

Two years into the pandemic, on 31 January 2022, government eased many of the COVID-19 response measures still in place – resuming full-time, in-person schooling and removing requirements for isolation by people with asymptomatic COVID-19. During his annual State of the Nation address on 10 February 2022, Pres. Ramaphosa said “We are now ready to enter a new phase in our management of the pandemic. It is our intention to end the national state of disaster as soon as we have finalised other measures under the National Health Act and other legislation to contain the pandemic. Nearly all restrictions on economic and social activity have already been lifted.”[20]

Government’s response to COVID-19 has been marked by both highs and lows, failures and victories.  Low-points of government’s response to COVID-19 have included: secrecy regarding how decisions are made and who makes these decisions[21]; corrupt use of financial budgets for COVID-19 (including, specifically, budgets for communications and PPE)[22],[23]; inadequate and delayed social support to alleviate increased economic hardship resulting from COVID-19, particularly among women[24]; insufficient planning and efforts to address the high levels of vaccine skepticism in the country[25]; inadequate planning and provisions to enable undocumented migrants to access COVID-19 vaccines[26], and failure to address intellectual property (IP) barriers and take on monopoly power that impedes health technology access at a national level.

High-points of the government’s response have included: strong global pushback against intellectual property and knowledge barriers impeding access to and local manufacture of COVID-19 health technologies; leadership and engagement at a continental level to highlight access inequities, secure access to health technologies, and build manufacturing capacity on the continent; and (while not without flaws) the national vaccine rollout which, as of 3 February 2022, has administered over 30 million vaccines. More than 40% of the adult population in the country is now considered fully vaccinated (receiving either two Pfizer vaccine doses or one J&J vaccine).[27]

Says Fatima Hassan, founder and director of Health Justice Initiative (HJI), “you have this group of known and unknown, at times unnamed experts who are also advising government, and they don’t want to tell us who they are. And, you know, for a long time, they just didn’t want to tell us what they were advising. So, it’s really bizarre, but at the same time, we’ve managed to administer over 28 million vaccines, managed to get vaccine supplies in, and our colour is slightly changing on that map of the world of the vaccinated and unvaccinated”.

At times, government’s response to COVID-19 has seemed schizophrenic or even contradictory. One area where government has seemingly pursued contradictory approaches has been in dealing with intellectual property barriers to COVID-19 health technology access and local manufacturing.

On the international stage, South Africa has strongly opposed patent barriers to COVID-19 health technologies. On 20 October 2020, South Africa, together with India, submitted a TRIPS waiver request at the World Trade Organisation (WTO) calling for a temporary suspension of granting or enforcing intellectual property protections on COVID-19 diagnostics, therapeutics and vaccines.[28] While the waiver has not been formally adopted (as a group of high-income countries continue to oppose the proposal), the waiver proposal has attracted widespread global support, from over 100 nations,[29] Nobel Laureates and former heads of state,[30] the International Commission of Jurists,[31] prominent IP scholars,[32] and a loose coalition of CSOs (including organisations that do not typically focus on trade and health).[33]

“The [South African] negotiators for the TRIPS waiver have done a fantastic job in moving the dial globally, around focusing global attention on how the WTO and IP laws do not serve poor people in a pandemic, and on ensuring that there was a movement of people around this idea that IP should not be prioritised in a pandemic, and not just for vaccines, but for diagnostics, therapeutics, even ventilators – so all lifesaving technologies,” says Hassan.

“Our government in the President et cetera, in this kind of TRIPS waiver, has been at the global stage at nearly the highest level to try and change these issues,” says Marvin Hsiao, senior lecturer and consultant virologist at University of Cape Town/Groote Schuur Complex of the National Health Laboratory Service.

In addition to championing the TRIPS waiver, Pres. Ramaphosa has frequently and firmly spoken out against IP barriers to COVID-19 health technology access, and their uneven impact on poor countries, while criticising wealthy countries for opposing the waiver proposal.[34] 

During the December 2021 Dakar International Forum on Peace & Security, Pres. Ramaphosa stated:  “The most critical aspect at this time however is the ongoing negotiations with the World Trade Organization (WTO) for a temporary waiver of the Trade Related Aspects of Intellectual Property Rights Agreement for the manufacture of COVID-19 vaccines[35]…Whilst this is being negotiated, this is where you really see that the interests of the more developed economies, the rich countries, through their refusal to accede to this proposal to waive the TRIPS requirement[36]…They are demonstrating that they are only interested in advancing the interests of their citizens, not the citizens of the whole world. This is the type of vaccine apartheid we say must come to an end, because the health of people around the world is at stake.”[37]

Yet, while South Africa has pushed for measures at an international level to address IP barriers to health technology access and manufacturing, it has failed to address ongoing IP impediments to health technology access within its national patent legislation.

South Africa amended its domestic patent legislation in 1997 to comply with the requirements of TRIPS (the Trade-Related Agreement on Aspects of Intellectual Property Rights). Under TRIPS, WTO-member countries are required to provide 20-year periods of patent protection on new inventions. While TRIPS requires that WTO member countries adopt stringent intellectual property rules, it also contains flexibilities that countries may incorporate into their national laws to promote public interest. In 2001, in the Doha Declaration on the TRIPS Agreement and Public Health, WTO member states affirmed the rights of countries to utilise flexibilities within the TRIPS agreement to promote and protect public health.[38]

While South Africa amended its national laws in 1997 to comply with TRIPS, it has still not adopted many of the flexibilities within the TRIPS agreement that can be applied to protect public interest and health into its national laws.

In 2011 – ten years after the Doha Declaration – the Treatment Action Campaign (TAC), SECTION27 and Médecins Sans Frontières (MSF) launched the Fix the Patent Laws campaign to advocate for pro-public health reform of South Africa’s patents laws. Over the past decade, the Fix the Patent Laws Coalition has grown to include over 40 civil society organisations (CSOs) working on a range of health issues in South Africa.

After seven years of sustained civil society activism, CSOs welcomed the release in August 2018 of the Intellectual Property Policy of the Republic of South Africa 2018 Phase I by the Department of Trade and Industry (DTI). The draft policy committed to reform South Africa’s patent laws to combat abuse by patent holders and protect public interest and health.[39]

More than three years later, however, government has not yet tabled a Bill in Parliament to reform domestic patent laws. On 9 December 2021, Fix the Patent Laws marched outside the Department of Trade and Industry, calling on the Department to “Immediately publish the amendments to the Patents Act drafted by the DTIC for public comment.”[40] 

“We delivered a memorandum as usual, but yeah, we didn’t really get anyone high up there receiving it and still no response till today,” noted interviewee 3.

Regional leadership by Pres. Ramaphosa

Pres. Ramaphosa served as Chairperson of the African Union (AU) from February 2020 through February 2021.[41] In this role, he has repeatedly spoken out against inequitable access to COVID-19 health technologies and championed initiatives to improve health technology access in Africa. As AU Chairperson, Pres. Ramaphosa established the Commission on African COVID-19 Response – chaired by himself and Africa CDC Director Dr John Nkengasong,[42] launched the African Medical Supplies Platform to pool purchasing power of African countries and simplify the procurement of COVID-19 health technologies for countries,[43] and established the African Vaccine Acquisition Trust (AVAT) to enable centralised purchasing of COVID-19 vaccines by AU members states.

After stepping down from the position of AU Chairperson in February 2021, Pres. Ramaphosa was appointed as the AU Champion on COVID-19. In this position, he has pushed for building vaccine manufacturing capacity in Africa and, in April 2021, supported the launch of the Partnership for African Vaccine Manufacturing (PAVM).[44]

Pres. Ramaphosa said in May 2021 during a high-level meeting on the future of vaccine manufacturing in Africa: “Our goal is to cover the entire vaccine production value chain by upgrading existing capacity and bringing new capacity on board. We want to establish new pharmaceutical manufacturing companies able to produce the COVID-19 and other vaccines.[47] 

At the launch of the Nant SA vaccine manufacturing campus on 19 January 2022, Pres. Ramaphosa stated “Our goal is to cover the entire vaccine production value chain by upgrading existing capacity and bringing new capacity on board. Emerging African manufacturers need technology partners to develop their skills base and assist with technology transfer.”  

In June 2021, Pres. Ramaphosa welcomed the announcement that the WHO mRNA vaccine technology transfer hub would be established in Cape Town, South Africa, stating: “South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort. With this investment of technology, knowledge and expertise, we will go beyond the development and manufacture of vaccines into a new era of innovation and progress.”[48]

In January 2022, Pres. Ramaphosa praised the establishment of Nant SA vaccine manufacturing campus in South Africa, stating: “We have seen that if we want to safeguard the health of our people, we need to have the means, the technology and the resources to produce vaccines and treatments for all the diseases that afflict the people of our continent. That is why we have been working to establish new pharmaceutical manufacturing capabilities to produce the COVID-19 and other vaccines. This Nant SA facility will make a vital contribution to this mission, complementing the work already being done by companies like Aspen, Biovac and Afrigen here in South Africa and several other companies in other parts of the continent.”[49]

Ensuring the sustainability of investments in manufacturing capacity

COVID-19 has shone a light on the gaps in South Africa’s capacity to move health technologies developed in the country from early research stages, or lab use, to commercial products. While the country produces finished pharmaceutical products, it has very limited capacity to produce the active ingredients required to make medicines. Its existing capacity to fill and finish certain vaccine products is being significantly expanded following investments and deals for COVID-19 vaccine manufacturing. The country, however, currently lacks capacity to manufacture the active drug product used for vaccination at commercial scales – or even the scale required for conducting clinical trials. At the same time, capacity to produce diagnostic products at a commercial scale is limited.

Multiple companies in South Africa (i.e., Afrigen, Biovac, Aspen, CapeBio) are now seeking to build manufacturing capacity for COVID-19 vaccines and drugs in South Africa – typically with financial and/or political support from government and scientific expertise/support from academia, the South African Medical Research Council, and other partners. Glaudina Loots, director of innovation at the Department of Science and Innovation told participants of MSF’s November 2021 webinar on COVID-19 diagnostics that “the thing that has helped the whole issue around health innovation in South Africa is we look at how we can build on one another’s strengths and then collectively actually assist a company to get to a product”, adding “if you don’t do it together, you will struggle in Africa”.

During his 10 February 2022 State of the Nation Address, Pres. Ramaphosa told the country “We will increase our efforts to develop Africa’s ability to manufacture vaccines. We have made significant progress here in South Africa. We now have two South African companies – Aspen and Biovac – with contracts to produce COVID-19 vaccines. Two additional vaccine projects have also been announced. In addition, we have full local production capability for ventilators, hand sanitisers, medical-grade face masks and gloves and therapeutic drugs and anaesthetics. This production capability worth many billions of rands of production annually, has been put in place in less than two years.”[50]

While multiple initiatives are underway to build health technology manufacturing capacity in South Africa, the sustainability of these efforts will require long-term investment and support. The Department of Science and Innovation (DSI) has long pushed for implementing preferential procurement mechanisms to ensure the sustainability of demand for local producers of health technologies.[51] Loots further noted during MSF’s November webinar that “a more centralised process of procurement, that needs to be committed to, to assist Africa first – but yes we can make [diagnostics] at competitive prices, we’ve proven it”.

According to Hsiao, in the diagnostic space, government funded research and manufacturing efforts have had a poor track record in actually bringing a product to market. Says Hsiao, “South Africa, when it comes to biotechnology and innovation, we have a history of the government funding some of these institutions and then they get to a certain stage, and I don’t know whether it’s a governance issue or there are some other kind of competence issues, but it just doesn’t get very further. And then the next iteration, there’ll be a slightly different institution trying to start to do the same thing”. “Without something to show for it, we’ll kind of continue to be stuck in this kind of early cycle. And it’s not from the lack of scientists because I think we do have plenty of those but there’s a huge gap between designing something that’s for research and some commercial product that is scalable”.

Ed Rybicki, director of the Biopharming Research Unit at the University of Cape Town, notes that there is a lack of transparency regarding how decisions are made by government related to funding awards and allocations for health research, and that large funding commitments and allocations are typically made to ‘preferred companies’, with little support trickling down to other research units and companies in the country.

Says Rybicki “There’s huge amounts of promise and people waving their hands wildly talking about the billions of euros [for funding local R&D and manufacturing], not a cent has trickled down. And there’s altogether an unsavoury amount of secrecy and wheeling and dealing at government levels… There seems to be too few people that are acting as a gateway…. that’s our problem in South Africa is getting the bloody stuff to trickle down in such a way that it doesn’t get channelled into preferred directions”,

Civil society activism builds awareness of IP barriers, but needed domestic law reform remains elusive

South Africa entered a hard lockdown in mid-March 2020 in response to what Pres. Ramaphosa termed “a medical emergency far graver than what we have experienced in over a century.”[52] Though no COVID-19 specific medical technologies existed at the time, civil society foresaw that patents and other intellectual property barriers would likely play a role in limiting access to needed technologies.

Thus, on 18 May 2020 a group of more than 80 prominent South African academics, researchers and teachers sent a letter to Pres. Ramaphosa calling on him to urgently reform domestic patent laws to ensure access to COVID-19 related health products. The letter was accompanied by a social media campaign headed by the Fix the Patent Laws (FTPL) Campaign[53] requesting that government take three steps to fight COVID-19 and ensure access to needed health technologies in South Africa: (1) institute a temporary moratorium on granting patents for COVID-19 products that are proven to be effective; (2) initiate automatic compulsory licensing on all COVID-19 health products with existing or pending patents; and (3) reform domestic patent laws to ensure full use of TRIPS flexibilities to protect and promote health.[54]

Since then, government has not taken any public steps to realise these demands, despite continued and coordinated activism by civil society organisations (CSOs) aimed at getting the Department of Trade, Industry and Competition (DTIC) to prioritise domestic patent law reform. These actions have included demonstrations outside the DTIC, social media campaigns, webinars, and op-eds. “Civil society has really been excellent at keeping [government’s] feet to the fire. So, linking into an existing fix the patent laws campaign, making sure that everybody understands what are all these factors… why it is important,” says Andy Gray, senior lecturer of pharmaceutical sciences at the University of KwaZulu-Natal.  

While the South African government has not instituted any of the domestic reforms advocated for by the FTPL coalition, it has been active in opposing intellectual property barriers to COVID-19 health technologies on the global stage – championing the call for a TRIPS waiver.

In South Africa, mobilisation around the TRIPS waiver has activated new organisations to engage in advocacy aimed at dismantling IP barriers to COVID-19 health technologies access. Their actions have had a number of successes, including improving public awareness about how patents and knowledge barriers impede access to medical technologies and drive vaccine nationalism. “I think the fact that there is engagement [around the TRIPS waiver], that people know that its South Africa’s recommendation, is as much due to civil society as it’s been due to government officials,” says Gray.

At the regional level, civil society mobilisation has contributed to building consensus amongst African Union member states regarding how patents impede manufacturing scale-up and access, and securing their explicit endorsement of the TRIPS waiver. According to interviewee 3, early advocacy efforts “were very targeted at the African Union…  it was actually getting them to acknowledge that IP is a barrier, which we did get. And then the TRIPS waiver discussions came in.” “I think civil society has done a great job in raising the awareness around IP and how it is a barrier… [especially] at the African Union level, [for example] they have, under this Partnerships for African Vaccine Manufacturing, they have a workstream solely dedicated to IP and tech transfer – which is something that you wouldn’t have seen pre-COVID times,” says interviewee 3.

Speaking about additional reforms that may emerge from the spotlight COVID-19 has shone on IP, Petro Terblanche, managing director at Afrigen Biologics, says, “I think that Africa as a continent is going to move towards [patent] examinations”, adding “this whole saga has sensitized the whole South African government to carefully look at our patent frameworks and our patent laws.”

Civil society mobilisation has also served to create some discomfort for pharmaceutical companies, who have been publicly shamed for profiteering in the midst of a global pandemic. Hassan notes that this “may have forced a few companies to give one or two fill and finish licenses and may have forced people to say: Okay, let’s just set up a Hub [to] keep these people at bay.” “It’s made companies really uncomfortable and investors do ask questions,” adds Hassan. 

Terblanche echoes the importance of advocacy in saying “the more advocacy and more pressure there is, the better. You know, Moderna can be stubborn to a point, but they’re a public company… depending on people buying the shares and people supporting the shares and not exiting.” COVID

Though Moderna has committed to not enforce patents during the pandemic, the company has been awarded patents in South Africa and retains the discretion to decide when to declare the pandemic “over”. This creates unpredictability about the prospects of commercialising any vaccines that the company deems to violate its patents, including those emerging from the WHO mRNA hub based in South Africa.

At the domestic level, civil society is credited with improving transparency around the vaccine rollout. According to HJI’s Hassan “without civil society, and a strong, independent media, a lot of the stuff just wouldn’t have come out. I mean, civil society, and the media, were tracking vaccine supplies, vaccine selection, vaccine deliveries, vaccine gaps, vaccine numbers, providing information on vaccine sites, doing educational workshops… there’s a lot it has done for free for this government, which they should have been doing, you know, we are even analysing and tracking MAC[55] advisories and cataloguing them”.

Many of civil society’s successes were attributed, at least in part, to the fact that South Africa had a pre-existing network of health CSOs. In particular, the struggle for universal access to antiretrovirals (ARVs) gave South African CSOs and activists a depth of experience and global networks they could turn to in advocating for removing intellectual property barriers on COVID-19 technologies. However, CSOs were less adept at translating other aspects of the struggle for ARVs into their COVID-19 advocacy work. More specifically, non-IP barriers to medicines, like vaccine denialism, have proved difficult to address. Partly, this can be attributed to the fact that data relating to newly developed COVID-19 vaccines and therapeutics were not always communicated fully and transparently by researchers and pharmaceutical companies.

The problem of transparency and data sharing regarding clinical trials on the part of researchers trying to protect proprietary (or potentially proprietary) information was identified by the United Nations Secretary General’s High-Level Panel on Access to Medicines as an impediment to equitable access to medicines. The Panel noted that “Transparency is necessary to hold governments, the private sector and other stakeholders accountable for the impact of their actions on access to health technologies” and has recommended that “To facilitate open collaboration, reconstruction and reinvestigation of failures, governments should require that study designs and protocols, data sets, test results and anonymity-protected patient data be available to the public in a timely and accessible fashion.”[56]

Says Hassan, “unfortunately, pharmaceutical companies and some researchers were pushing data based on press statements and were making decisions in the absence of peer reviewed data. And I mean, a lot of clinical announcements by drug companies initially were by press statement… So, there’s also context [in] which… you have to question, but you can question in a way where you don’t fuel hesitancy”.

She adds, “Look, we’ve all failed to an extent, government, business, unions, parliament civil society, all of us failed around the anti-vax movement… we’ve really pushed, but we all underestimated it… we have to do a lot more work around [building public understanding of] science and evidence in a context of a pandemic… and that takes time. I mean, with HIV AIDS, that took years…. trying to deal with denialism.”

What might the legacy of the current wave of civil society mobilisation against intellectual property barriers to COVID-19 health technologies be? Interviewee 3 believes that governments on the continent have become more nuanced in their assessments of the “benefits” of sub-licensing and tech transfer agreements: “You know, initially we’d get so excited that we have an agreement on the fill and finish, and we’d call that a manufacturing agreement, I think there definitely will be a move in terms of what our demands are, when we come into the negotiation table.”

Interviewee 3 adds that in addition to pushing for more than fill and finish agreements, governments are now more likely to push back against commitments to build manufacturing facilities on the continent without tech transfer: “They are like: No, this is not a tech transfer, you can’t tell us that you’re bringing your own property, you’re bringing your own staff, you know, that’s definitely not a tech transfer for us. A [true] tech transfer…  means more independence for the local manufacturer.” She adds “that in itself is a level of empowerment that we previously maybe have not seen.”

However, interviewee 3 also notes that – at a domestic level – the legacy of advocacy efforts is unclear as they have not translated into actions by local officials to reform domestic patents law to improve health technology access and enable expanded local manufacturing.

Says Gray, ““what about amending our own Patents Act? What about addressing patentability standards in the country? We can’t continue to strut around on the global stage making a fuss and saying what should be fixed elsewhere and we’ve failed horribly to fix what we should be fixing at home.” He adds, “it would really help if we could say this is what we’ve done at home to make sure that we can use the waiver to the best of our ability, and we haven’t done that.”

Table 1. A timeline of civil society action to overcome IP barriers to COVID-19 health technology access

DateSummary
May 18, 2020A group of more than 80 prominent academics, researchers and teachers send a letter to Pres. Cyril Ramaphosa calling on him to urgently reform domestic patent laws in order to increase access to COVID-19 related health products. The letter is accompanied by a FTPL social media campaign requesting 3 steps to fight COVID-19 in South Africa: (1) A temporary moratorium on granting patents for COVID-19 products that are proven to be effective; (2) Automatic compulsory licensing on all COVID-19 health products with existing or pending patents; and (3) Reforming domestic patent laws to ensure full use of TRIPS flexibilities.[57]  
October 2020  FTPL launches an online petition aimed at pressuring the SA government to amend domestic patent laws in order to increase access to patented medications, including those needed to treat and prevent COVID-19.[58]  
October 2, 2020India and South Africa submit the TRIPS waiver request at WTO calling for a temporary waiver of all TRIPS rules on COVID-19 therapeutics, diagnostics and vaccines.[59]  
October 5, 2020  FTPL writes to Minister of Trade and Industry, Ebrahim Patel, requesting an update on the status of the draft legislation implementing the Intellectual Property Policy.[60]  
October  15, 2020  FTPL releases a press statement supporting India and South Africa’s request for a temporary TRIPS waiver on all COVID-19 therapeutics, diagnostics and vaccines tabled at the WTO and together with other civil society organisations globally call on WTO members to endorse the request.[61]  
December 8, 2020FTPL participates in a twitter storm aimed at pressuring the EU Commission, France, Brazil, USA, Australia, Japan, and Canada to support the TRIPS waiver and temporarily suspend laws enabling monopolies over COVID-19 health technologies.  
December 10, 2020PHM SA in collaboration with partners on its Equitable Access to C-19 Technologies project hosts a webinar on regulatory and IP “Barriers and Enablers to Equitable Access to COVID-19 Health Technologies in South Africa”.[62]  
January 12, 2021Peoples Vaccine Campaign of South Africa is formed. Their call to action urges support for the TRIPS waiver request in order to build vaccine production capacity and technology transfer in the global south.[63]  
January 31, 2021  Archbishop Thabo Makgoba, writing on behalf of the Peoples Vaccine Campaign South Africa, sends a letter to Dr Tony Fauci, Dr Rochelle Walensky, Dr David Kessler, Dr Vivek Murthy, and Dr Marcella Nunez-Smith requesting that they act to ensure that the US government shares know-how involving the production of the Moderna vaccine, and issue multiple licenses for production of the vaccine to ensure increased supply, including for the global south.[64]  
February 2-5,  2021MSF in collaboration with FTPL and the Peoples Vaccine Campaign delivers letters to embassies of countries blocking the TRIPS waiver request together with a twitter storm aimed at amplifying this message.[65]  
February 25, 2021International Labour, Research and Information Group (ILRIG) hosts a webinar on “COVID-19 Vaccines: The New Apartheid?” featuring analyses of how public funding contributed to the development of multiple effective COVID-19 vaccines which are treated as the private property of private pharmaceutical corporations under the TRIPS regulations, a situation which has contributed to constrained production of vaccines globally.[66]  
March 11, 2021PVC SA launches a Day of Action against vaccine apartheid and TRIPS waiver blocking. Actions include a press conference and demonstration outside of Johnson & Johnson’s Cape Town offices.[67]  
March 18, 2021Fix the Patent Laws campaign marches to the DTIC to demand that Minister Patel urgently release draft legislation aimed at realising the South African Policy on Intellectual Property, Phase 1 for public comment, and then table the bill in parliament. Minister Patel’s Chief of Staff, Mr Moosa Ebrahim, received and signed a memorandum handed over by activists.[68]  
May 28, 2021FTPL coalition organises a twitter storm aimed at Pres. Macron during his official visit to South Africa calling on him to support the TRIPS waiver request.  
April 29, 2021FTPL hosts a webinar on “Mobilising Support for Patent Law Reform Locally and Internationally” with Achal Prabhala (Access IBSA/Shuttleworth Foundation), Dr Tlaleng Mofokeng (UN Special Rapporteur on the Right to Health), Leena Menghaney (Director of the MSF Access Campaign in India and South Asia), and Umunyana Rugege (SECTION27 Executive Director).[69]  
June 4, 2021Health Justice Initiative releases an infographic on “Frequently Asked Questions: The TRIPS waiver and the WTO”[70]  
July 9, 2021Health Justice Initiative tables a Submission on the Copyright Amendment Bill [B13B-2017] that calls for the government to recognise “the right to repair” and draws attention to the importance of this right in relation to life-saving medical technologies, and specifically in the context of the COVID-19 pandemic, the right to repair technologies such as medical ventilators. It also calls for a broader endorsement of “the right to research” than the one currently proposed, in order to support knowledge production related to COVID-19 and other medical conditions. Finally, the submission encouraged Parliament to enact domestic patent and copyright law reform that would enable immediate use of existing TRIPS flexibilities.[71]  
August 19, 2021The ICESCR Civil Society Coalition Campaign organises a webinar on “The Right to Health and Equitable Access to COVID-19 Health Technologies” which features analysis from Candice Sehoma (MSF), Prof. Yousuf Vawda (UKZN) and Prof. Rodrigo Upriminy (National University of Columbia and Member of the UN Committee on Economic, Social and Cultural Rights) on how the global IP regime impedes the right to health in the context of the COVID-19 pandemic.[72]  
August 23, 2021Health Justice Initiative releases an “Explainer on Vaccine Licenses for COVID-19”[73]  
September 3, 2021FTPL launches a video entitled “Why TRIPS acts as a barrier to the C-19 vaccine and how to change it!” based on the “Train the Trainer Vaccine Literacy and Advocacy Manual” developed by health activist organisations including the PVC SA, SECTION27, Workers World Media, Health Justice Initiative, PHM South Africa, and MSF Southern Africa.[74]  
September 14, 2021Activists protest outside the Union Buildings in Pretoria demanding that Germany stops blocking the TRIPS waiver request as part of an Africa-wide campaign targeting the German government.[75]  
September 22, 2021PHM South Africa hosts a webinar on “Lessons from HIV/AIDS access to medicines campaign for the TRIPS waiver” in which Kajal Bhardwaj (IP lawyer) and Sibongile Tshabalala (Treatment Action Campaign) speak on IP and health systems challenges that impede equitable access to HIV/AIDS medical technologies and health care and which continue to negatively affect COVID-19 care.[76]  
October 12, 2021FTPL organises demonstrations outside embassies of countries blocking the TRIPS waiver request demanding that they support the waiver.[77]  
October 13, 2021PHM South Africa and Health Justice Initiative launch a video advocating for the TRIPS waiver request. Entitled “Vaccine Patents Kill! A Message on the TRIPS waiver From South Africa”, the video includes voices of South African health activists explaining how IP laws impede vaccine access and how the TRIPS waiver can help facilitate vaccine equity.[78]  
November 9, 2021FTPL activists march to the DTI to urge the government to reform our intellectual property laws to enable improved access to lifesaving medicines for COVID-19 and other life-threatening diseases. Demands include publishing the amendments to the Patents Act drafted by the DTIC for public comment, issuing compulsory licenses for COVID-19 treatments and vaccines, and reviewing the legal status of patent applications on all COVID-19 medical technologies, including granted or pending applications on Moderna’s mRNA vaccine.[79]  
November 11, 2021PHM South Africa organises a webinar comparing the historical experiences with local manufacturing of vaccines in South Korea (Sun Kim – PHM Brazil), Brazil (Gustavo Matta – Fiocruz) and South Africa (Patrick Tippoo – Biovac) that reflects on some of the IP challenges to building this capacity.[80]  
November 25, 2021South African health activists Tinashe Njanji (PHM South Africa) and Fatima Hassan (Health Justice Initiative) are panellists on a global press conference aimed at briefing health and trade journalists on why a TRIPS waiver is central to a fair and equitable approach to managing the COVID-19 pandemic.  
November 30, 2021PHM South Africa in collaboration with PHM Global and Public Services International organise an international twitter storm in support of the TRIPS waiver, and as part of a broader set of activities around WTO MC12 coordinated by Our World is Not For Sale network.  

Moderna refuses to cooperate with efforts to build mRNA manufacturing capacity in Africa

To date, Moderna has not supplied any of its COVID-19 vaccines to South Africa outside of a clinical trial. Only 17.6% of Moderna’s total vaccine supply has been delivered to low-and middle-income countries, while only 0.2% of the total supply has gone to low-income countries.[81] During October 2021, the New York Times published an exposé demonstrating how Moderna has both ignored requests for, and failed to deliver, supplies of its COVID-19 vaccine to poor countries, while prioritizing delivery of orders from wealthy countries. And, despite ongoing secrecy from Moderna regarding how much it is charging different countries per dose for its vaccine, the New York Times analysis found that, in several cases, Moderna is charging poor countries far more for its vaccine than wealthy ones.[82]  

Despite not supplying any vaccines to the South African market, Moderna has filed and received several patents on its COVID-19 vaccine in the country.[83] The patents granted in South Africa are a significant impediment to efforts of the WHO mRNA Technology Transfer Hub to develop mRNA manufacturing capacity in Africa and other developing regions where access to adequate vaccine supplies remains a challenge.

The WHO announced the establishment of an mRNA Technology Transfer Hub to develop and share capacity for mRNA manufacturing in underserved, developing regions during June 2021. The Hub was established at Afrigen – a biotechnology company based in Cape Town, South Africa – and brings together a network of partners (Afrigen, Biovac, the South African MRC, the Africa CDC, and the Medicines Patent Pool) to develop the know-how and capacity to produce mRNA vaccines. Know-how and capacity developed at the Hub will then be transferred to commercial manufacturers around the world. In South Africa, Biovac – a partially state-owned vaccine manufacturer that is primarily focused on fill, finish, and distribution of vaccines – will seek to commercialise mRNA vaccine developed at the Hub.

Despite intense efforts by the Hub to secure a ‘turn-key’ technology transfer from Moderna or Pfizer to aid the Hub in developing mRNA vaccine manufacturing capacity and a technology transfer package for commercial partners, neither company has cooperated with efforts at the Hub.

Afrigen’s managing director, Petro Terblanche, told participants at the December 2020 African Union stakeholder engagement on the Partnership for African Vaccine Manufacturing (PAVM) that “The Hub was designated to receive turn-key technology transfer, in the absence of that… we are doing it ourselves, not with a technology transfer but with knowledge transfer, partnerships, and technical support across the globe”.

Terblanche told Reuters “We started with the Moderna sequence because that gives, in our view, the best starting material. But this is not Moderna’s vaccine, it is the Afrigen mRNA hub vaccine”.[84]

Moderna is seeking to develop a booster vaccine using the genetic sequence from the Omicron variant, which was discovered in South Africa. No commitments to recognise the contributions of South African researchers though access or other arrangements have been made.

In January 2022, Afrigen announced that it had successfully produced a batch of mRNA vaccine drug product using the genetic sequence used to develop Moderna’s vaccine.[85] Reuters reported that Afrigen “had managed to make, in collaboration with Johannesburg’s University of the Witwatersrand, its first micro-litre laboratory scale batches of COVID mRNA vaccines at the Cape Town facility”. Terblanche told Reuters “We will only make our clinical trial batch probably in six months from now, (meaning) … fit for humans. And the target is November 2022.”[86]

Afrigen is seeking cGMP status (certification of its Good Manufacturing Process) for its vaccine manufacturing facility, which it will enable the Hub to begin manufacturing mRNA vaccines for use in clinical trials.

Afrigen has been able to ‘reverse engineer’ Moderna’s mRNA vaccine by taking advantage of Moderna’s pledge not to enforce patents during the pandemic and by utilising the Bolar exception contained in South Africa’s patent laws and permitted under the TRIPS agreement. The Bolar exception allows “generic producers to research, create, and test a patented product before the end of term of the patent”.[87]

Says Terblanche “under the Bolar Exemption, up to end of phase 3, we are completely free to operate”, adding “we will be able to develop this vaccine up to phase 3 clinical trials, but we cannot go into the clinic without Moderna’s voluntary license, or a compulsory license”. She adds “we’re building platforms here that’s relevant for future pandemics and if we don’t get IP sharing, those platforms cannot operate.”

Fix the Patent Laws has called on the South African government to adopt a broad research use exemption in its domestic patent laws to broaden the legal space for research and development of local scientific and technical capacity.

Moderna has filed eight patents related to its COVID-19 mRNA vaccine in South Africa to date: four of which have been granted, three of which remain pending, and one of which has been withdrawn. The claims in the patents filed by Moderna are so broad that they could impede the manufacturing and marketing of not just competitor versions of its mRNA vaccine, but any mRNA vaccine.[88]

Moderna is facing ongoing disputes over its patent claims internationally, including with the U.S. National Institutes of Health and other companies. In South Africa, where patents are granted without examination of their merits, or their potential impacts on public interest, Moderna has received broad patent protection with little scrutiny or resistance.

Table 2. Patents filed by Moderna in South Africa

Product NamePatent DescriptionPatent StatusPatent Application DatePatent Application NumberExpected Expiry Date
mRNA-1273 (pINN Elastomeran) 0.5 mlCompositions and methods for delivering modified mRNA into cells to modulate protein expression (production of immunoglobulins)Granted5/20/2014ZA20140366610/3/2031
Compositions and methods for delivering modified mRNA into cells to modulate protein expression (production of immunoglobulins)Granted4/30/2013ZA20130316110/3/2031 
Compositions and methods for delivering modified mRNA into cells to modulate protein expression (production of immunoglobulins)Filed4/29/2014ZA20140311910/3/2031 
Method of expressing a polypeptide by administering an isolated mRNAGranted10/3/2012ZA20140254710/3/2032 
Method of producing a polypeptide in a mammalian cell or tissue with a formulation comprising a modified mRNA encoding the polypeptide; Pharmaceutical compositions comprising modified mRNA formulated in LNPsFiled5/21/2015ZA20150362112/14/2032 
Method of producing a polypeptide in a mammalian cell or tissue with a formulation comprising a modified mRNA encoding the polypeptide; Pharmaceutical compositions comprising modified mRNA formulated in LNPsFiled5/23/2014ZA20150362012/14/2032 
Method of producing a polypeptide in a mammalian cell or tissue with a formulation comprising a modified mRNA encoding the polypeptide; Pharmaceutical compositions comprising modified mRNA formulated in LNPsGranted5/23/2014ZA20140378312/14/2032 
Method of expressing a polypeptide by administering an isolated mRNAWithdrawn6/7/2017ZA201703921 

*Table exported from VaxPal on 25/01/2022

Interviewee 3 explains “Moderna has filed and been granted patents in South Africa… [which] could potentially block the mRNA Hub from commercializing the vaccine once it’s ready to be in the market”. She adds “Moderna said they won’t enforce any patents until the pandemic is over, but… it’s upon their discretion to also decide when the pandemic will be over and it can be over when Afrigen is ready to put their product out”.

“Moderna claims that they are not enforcing patents, but they are actually registering patents and then making it really difficult by creating all these obstacles and not explicitly cooperating with the Hub… its meant that more time was wasted to try and get other players into the field,” says Hassan.

Moderna’s ongoing refusal to participate with the Hub and transfer technology is slowing efforts by the Hub to expand mRNA vaccine manufacturing capacity to address severe supply shortages in poor-countries. The lack of cooperation by Moderna has meant that Afrigen has had to develop know-how and capacity to make mRNA vaccines ‘from scratch’, will necessitate that Afrigen develop its own quality procedures and systems, and will require that the Hub undertakes more extensive and time-consuming clinical trials of its vaccine candidate.

Terblanche explains “If we had a full tech transfer, we would probably be able to fast track the vaccine’s registration and we would have the legal IP landscape to operate in, so we may not have to do three years of clinical trials. So, I think it’s between six months and two years that I think we will lose”. She added “the other component is a tech transfer would have given us all the SOPs[89] and all the quality control and quality assurance systems that we need for registration, and we don’t have that, so we have to develop it ourselves. That’s pretty tough”.

Interviewee 3 says regarding Moderna’s ongoing refusal to share its technology with the Hub: “it’s time wasting, it’s resource wasting, and unfortunately we are not even guaranteed that, in the event that the mRNA Hub is ready to commercialize that they would be in a position to actually get that vaccine in the market.”

Table 3. A timeline of key events related to local access and manufacturing of Moderna’s COVID-19 vaccine in South Africa

DateSummary
2012 – 2032While Moderna has not sought registration of its COVID-19 vaccine in South Africa, it has sought and received four patents (ZA201303161, ZA201402547, ZA201403666, ZA201403783) related to its vaccine in the country, all of which have been granted without examination of their merits for patentability or consideration of their potential impacts on local access and manufacturing. The granted patents were applied for between 2012 and 2014 and continue through 2031 and 2032.[90]  
October 8, 2020Moderna announces that it will not enforce patents for the duration of the pandemic. Medicine access advocates call the announcement as a PR-stunt that will not truly advance expanded manufacturing and access as the announcement fails to provide required technology transfer to enable manufacturing by other companies and provides Moderna with discretion in determining when the pandemic is ‘over’ and resuming enforcement of its patents. The uncertain timeline provides significant legal uncertainty for companies and countries seeking to develop local manufacturing capacity and disincentivizes required investment.[91]  
December 18, 2020The U.S. Food and Drug Administration grants Emergency Use Authorisation for the emergency use of Moderna’s COVID-19 vaccine to prevent COVID-19 in the United States.[92]  
January 6, 2021The European Union’s European Medicines Agency grants conditional marketing authorisation to Moderna, allowing the company to market its COVID-19 vaccine in the EU.[93]  
April 13, 2021Moderna’s CEO Stéphane Bancel tells the participants at the African Union Conference on Vaccine Manufacturing in Africa that because mRNA is a new technology there is a shortage of individuals with the required skills needed to transfer technology and know-how to companies in Africa.[94]  
April 30, 2021The World Health Organisation grants Moderna Emergency Use Listing for its COVID-19 vaccine, allowing countries – including South Africa – to expedite their own review and approval of the vaccine for in-country use.[95]  
May, 2021Moderna’s Bancel tells analysts on a call that he is not worried about the TRIPS waiver proposal, as “You cannot go hire people who know how to make mRNA: Those people don’t exist.”[96]  
June 21, 2021The World Health Organisation announces the establishment of an mRNA Technology Transfer Hub to capacitate African manufacturers to make mRNA vaccines. The Hub is based in South Africa and will bring together a network of partners including Afrigen, Biovac, the South African MRC, the Africa CDC, and the Medicines Patent Pool.[97]  
October 7, 2021Moderna announces it will build a factory in Africa to manufacture vaccines, yet does not provide a timeframe for doing so, and continues to refuse to transfer technology and license existing vaccine manufacturers in Africa to produce its COVID-19 vaccine.[98]  
October 13, 2021United States Senators Elizabeth Warren, Jeff Merkley, and Pramila Jayapal protest Moderna’s ongoing refusal to share its technology to expand vaccine manufacturing despite receiving nearly US$ 10 billion in public funding from the U.S. government for the vaccine’s development.[99]   
October 21, 2021A report by the People’s Vaccine Alliance showed that as of October 2021, only 17.6% of Moderna’s total vaccine supply has been delivered to low-and middle-income countries, while only 0.2% of the total supply has gone to low-income countries.[100]  
October 26, 2021Moderna announces that it will supply 110 million doses of its COVID-19 vaccine to the African Union through 2022. The People’s Vaccine Alliance responds: “After having so far delivered zero of their committed doses to COVAX, this new Moderna Memorandum of Understanding with the African Union to at some point deliver 110 million more vaccines is barely worth the paper it is written on. This is a publicly funded vaccine and should be available to all as a public good. It is beyond time that the US government step in and insist the vaccine technology is shared immediately with the WHO mRNA technology hub.”[101]  
October – November 2021Global media reports highlight efforts by Afrigen, through the mRNA Technology Transfer Hub, to “reverse engineer” Moderna’s COVID-19 vaccine as a step towards enabling African-based manufacturing to address vaccine inequity between wealthy and poor countries.  
November, 2021Moderna projects that it will earn up to US$18 billion from the sale of its COVID-19 vaccine during 2021.[102]
November 10, 2021FTPL highlights that, despite pursuing patents, Moderna has not sought registration of its vaccine in South Africa, or delivered a single dose to the continent.[103]
November 26, 2021Moderna announces it will develop a vaccine candidate that will specifically target the Omicron variant – drawing on research undertaken, and knowledge generated in South Africa where the Omicron variant was first discovered.[104]  
December 1, 2021The COVID-19 Prevention Network initiates a trial to evaluate the efficacy of Moderna’s COVID-19 vaccine in preventing COVID-19 disease in people living with HIV. The trial will be conducted in eight sub-Saharan African countries, including South Africa.[105]  
December 6 – 7, 2021Afrigen’s Managing Director Petro Terblanche tells attendees of the Partnership for African Vaccine Manufacturing (PAVM) public stakeholder meeting that efforts to seek technology transfer from Moderna to enable African-based manufacturing of Moderna’s COVID-19 vaccine have been unsuccessful to date, yet notes that despite this “We are in fact developing end-to-end mRNA vaccine manufacturing capabilities and capacity, we are doing it ourselves, not with a technology transfer but with knowledge transfer, partnerships and technical support across the globe”. [106]
end-2021Moderna continues to refuse to license intellectual property and transfer technology to enable manufacture of its mRNA vaccine by African companies.  
January 1, 2022Politico reports “The team at the world’s first transfer hub for mRNA coronavirus vaccine technology had reason to celebrate… After failing to get Moderna on board to share its mRNA technology, the Cape Town hub went ahead, anyway. It has produced the drug product formulation in just more than six months since the initiative was announced. While the product is currently more of a “training batch” than the finished product, it’s a starting point for Afrigen — the developer behind the hub — to tinker with”.[107]  

Pfizer opposes TRIPS waiver and ducks WHO efforts to enable African countries to manufacture mRNA vaccines

South Africa received its first shipment of just over 300 thousand doses of Pfizer’s COVID-19 vaccine on 2 May 2021. As more doses arrived – and following a decision of the South African government not to use the AstraZeneca vaccine and slow delivery of vaccines from Johnson & Johnson (J&J) – Pfizer’s COVID-19 vaccines became the backbone of South Africa’s national vaccination programme.

After intense negotiations around the terms of the contract and successful push-back by South Africa against putting up sovereign assets to indemnify Pfizer against lawsuits related to use of the vaccine[108], South Africa signed a deal with Pfizer to supply 30 million vaccine doses to the country at US$10 per dose (~R150).[109]

An additional 7.8 million doses of the Pfizer vaccine have been donated to South Africa by the United States and 1.4 million doses have been procured through COVAX.[110] According to statistics from the Department of Health, as of 25 January 2021, 29 million COVID-19 vaccine doses have been administered in South Africa – 22 million of which were doses of the Pfizer vaccine.[111]

While South Africa has significantly scaled up access to COVID-19 vaccines, with Pfizer’s vaccines at the center of the national roll-out, vaccine supplies from Pfizer only began to trickle into the country in May 2021 – a whole four and half months after the United States began rolling out Pfizer’s COVID-19 vaccines.[112]

As of end-January 2022, just over 16 million people in South Africa are considered fully vaccinated, having received two doses of Pfizer’s vaccine or one dose of J&J’s vaccine. This accounts for 41% of the country’s adult population[113], or 28% of the whole population.[114] Across the African continent, however, only 15% of the population has received at least one COVID-19 vaccine dose.[115]

The People’s Vaccine Alliance report A Dose of Reality published in October 2021 shows how vaccine manufacturers including Pfizer have prioritized delivery of COVID-19 vaccines to high-income countries over poor countries, leading to highly inequitable vaccination access and rates across the globe. The report found that “Pfizer/BioNTech has sold eight times as many doses to high-income countries compared to doses sold to low and low-middle-income countries”[116], this is despite high-income countries only accounting for 16% of the global population.

The report added that “Pfizer/BioNTech and Moderna have spent most of the pandemic refusing to work with or ignoring many producers situated in low- and middle-income countries, or as is the case recently with Pfizer, only signing ‘fill and finish agreements’ that do not expand supply of the drug substance. Such agreements also do not enable LMICs to produce enough supplies for their own populations independent of corporate control”.[117]

On 21 July 2022, Pfizer and BioNTech announced a fill and finish agreement to enable Biovac to manufacture finished dose of the companies’ COVID-19 vaccine with drug substance obtained from Europe.[118] At the same time the company has failed to cooperate with or opposed efforts to enable drug substance manufacturing on the continent – which is critical to creating real capacity on the continent and expanding vaccine access and supply security.

While Pfizer has not pursued previous patents filed through WIPO’s Patent Cooperation Treaty in South Africa[119], Hassan notes that Pfizer has hoarded knowledge and undermined efforts to transfer knowledge to expand vaccine manufacturing capacity, including in Africa (the Biovac agreement is only for fill and finish). Pfizer’s CEO, Albert Bourla, has also openly opposed the request for a waiver of countries patent requirements under TRIPS during the pandemic.[120]

“It’s less about them filing patents, but obviously, you know, they have a monopoly,” says Hassan, adding “Pfizer has been about a drip feed of supplies, but holding on to their knowledge so much knowing that… I think quite early on they realised that they hit on a goldmine, right? And so, if you’re starting to administer third and fourth Pfizer shots, they want to hold onto their knowledge, because this is just such a massive commercial success for them, one of the most successful for them actually”.

Says Hsiao “my suspicion is that [Pfizer and Moderna] have bought enough time, so that… by the time all of this happens, by the time all of this is done [a local product is ready], we’re going to have a world that’s both highly vaccinated and highly infected. And then the value of the vaccine is dropped by quite a lot”.

In addition to Pfizer’s agreement with Biovac for fill and finish of its COVID-19 vaccines, BioNTech announced an agreement in October 2021 with the Rwandan and Senegalese governments to initiate the construction of an mRNA vaccine manufacturing facility in Africa. The agreement has been criticised by civil society for bypassing the efforts of the WHO to establish an mRNA Technology Transfer Hub to transfer existing intellectual property and technology to vaccine manufacturers in Africa to enable the manufacturing of COVID-19 mRNA vaccines on the continent. The agreement indicates BioNTech’s intention to manufacture future mRNA vaccines under development for neglected diseases like malaria and TB on the continent, but not BioNTech’s approved and urgently needed COVID-19 vaccine.

Says interviewee 3, “The strategy… is a way of  kind of a way… to say ‘look at us, we’ve made this commitment, [we’re] putting money on this and this’ and trying to kind of blind us to the bigger solution… that’s actually needed currently.”

While neither Pfizer nor BioNTech have filed patents on their COVID-19 vaccine in South Africa to date, the details of two international patent applications related to the companies’ COVID-19 vaccine filed through the Patent Cooperation Treaty were published in October 2021. Pfizer and BioNTech have until 22 October 2022 to select which countries they will pursue national patents in, including South Africa. These patents include an application by BioNTech (WO2021213924 A1) which covers the mRNA composition and an application by Pfizer and BioNTech (WO 2021/213945 A1) related to packaging and storing of the vaccine.[121]

Table 4. A timeline of key events relevant to access and local manufacturing of the Pfizer/BioNTech COVID-19 vaccine

DateSummary
April 29, 2020Pfizer and BioNTech initiate a large study in six countries, including South Africa, to evaluate the safety and efficacy of their COVID-19 vaccine. [122]  
September, 2020BioNTech secures a US$ 450 million grant from the German government to support its vaccine development.[123]  
December 11, 2020The U.S. Food and Drug Administration grants Emergency Use Approval for Pfizer/BioNTech’s COVID-19 vaccine allowing for marketing and use of the vaccine in the United States.[124]  
December 21, 2020The European Medicines Agency grants Conditional Marketing Authorisation to Pfizer/BioNTech allowing for the use of the company’s COVID-19 vaccine in the EU.[125]  
December 31, 2020The World Health Organisation grants Emergency Use Listing status to the Pfizer/BioNTech vaccine, allowing countries – including South Africa – to expedite their own regulatory reviews of the vaccine.[126]  
February 6, 2021Pfizer and BioNTech initiate a trial in five countries, including South Africa, to evaluate the safety and tolerability of their COVID-19 vaccine in pregnant women.[127]  
February, 2021U.S. government agencies, BARDA and the Department of Health and Human Services, increase their advance market commitment for procurement of the Pfizer/BioNTech vaccine for use in the United States to US$6 billion.[128]  
March 16, 2021The South African Health Products Regulatory Authority authorises the use of Pfizer/BioNTech’s COVID-19 vaccine in South Africa under Section 21 of the Medicine Act.[129]  
April 19, 2021The Mail&Guardian reports that South Africa has signed a contract to buy 30 million doses of the Pfizer/BioNTech COVID-19 vaccine at $10 per dose.[130]
May 2, 2021South Africa receives its first shipment of 325,260 doses of Pfizer/BioNTech COVID-19 vaccines.[131]  
May 7, 2021Pfizer CEO Albert Bourla publishes an open letter to employees opposing the TRIPS waiver championed by South Africa and India to enable low-and middle-income countries to locally manufacture COVID-19 health technologies, including vaccines, to address global supply shortages.[132]  
July 21, 2021Pfizer and BioNTech announce a deal with the South African vaccine manufacture Biovac. The deal will enable local fill and finish of the Pfizer/BioNTech vaccine in South Africa for distribution across Africa, but does not include licensing or technology transfer to enable manufacture of the vaccine’s active drug substance in South Africa.[133]  
August 25, 2021BioNTech initiates a trial in four countries, including South Africa, to evaluate the safety and efficacy of their vaccine when provided as a third booster shot.[134]  
October 12, 2021A report by the People’s Vaccine Alliance showed that as of October 2021, only a quarter of the total delivered supply of the Pfizer/BioNTech vaccine has gone to low- and middle-income countries, while only a meagre 0.4% of total supply went to low-income countries.[135]  
October 20, 2021BioNTech announces an agreement with the Rwandan and Senegalese governments to initiate the construction of an mRNA vaccine manufacturing facility in Africa. The agreement is criticised by civil society for bypassing the efforts of the WHO to establish an mRNA Technology Transfer Hub to transfer existing intellectual property and technology to vaccine manufacturers in Africa to enable the manufacturing of COVID-19 mRNA vaccines on the continent.[136]  
November 2, 2021Pfizer projects that it will earn US$36 billion during 2021 from the sale of its COVID-19 vaccine.[137]
January 25, 2022The South African Health Products Regulatory Authority registers Pfizer/BioNTech’s COVID-19 vaccine.[138]

Diagnostic goliath, Cepheid, holds onto its monopoly power at the expense of ramped-up testing during pandemic

Cepheid’s GeneXpert diagnostic platforms can be used to diagnose a broad range of infectious diseases, including COVID-19. The platforms can process multiple diagnostic tests simultaneously, providing results within a few hours. Significant public and philanthropic investment enabled the development of Cepheid’s diagnostic platforms as a potential game-changing technology for disease detection and outbreak response in poor nations. However, Cepheid has subsequently found that in addition to poor countries, there is also a large market for its easy-to-use, near-point-of-care diagnostic platforms in wealthy countries.

In the early days of the COVID-19 pandemic, South African policy makers and officials at the Africa CDC respectively highlighted the readiness of South Africa and the continent to rapidly scale-up diagnostic testing for COVID-19, due to their investments in rapid, high-throughput diagnostic platforms including, in particular, Cepheid’s GeneXpert diagnostic platform.[139] The Africa CDC estimated that 1.6 million COVID-19 tests could be done weekly using Cepheid GeneXpert diagnostic systems installed across the continent.[140]

Yet despite the availability of Cepheid’s diagnostic infrastructure to rapidly scale-up COVID-19 in many parts of Africa, including South Africa, African countries found themselves shut out of the market as global demand for Cepheid’s COVID-19 test cartridges outpaced supply and wealthy countries rapidly cornered available supply.[141]

John Nkengasong, head of the Africa CDC, wrote in April 2020 that despite having the money to buy COVID-19 test materials, African countries were unable to access adequate supplies due to a breakdown in global cooperation and solidarity in responding to the pandemic, which allowed wealthy countries to cannibalise available supply.[142] “A race is on by the powerful to acquire whatever COVID-19 tests are available,” said Nkengasong.   

Yenew Kebede Tebeje, head of laboratory systems at the Africa CDC, said during MSF’s November 2021 webinar on COVID-19 diagnostics that: “During the first phase of pandemic, the first 6 months, [it was a] really daunting task to get diagnostics into Africa. For example, for GeneXpert…  in Africa there are more than 21 000 modules, which means that Africa can do more than 11 million tests in one year using that platform even without affecting HIV testing. However, we used only 5% of that potential because the diagnostic cartridges were not available and the African market has not been prioritized.”

Recognising that shortages of Cepheid’s COVID-19 test cartridges for use on GeneXpert testing platforms would be a barrier to testing scale-up, the South African government reached out to Cepheid early in the pandemic to seek technology transfer to enable domestic manufacture of the test cartridges in short supply.[143] According to interviewee 3 those efforts “fell away because the company was not responsive” to South Africa’s requests.

Hsiao says that while South Africa does not currently have capacity to produce Cepheid’s specialized test cartridges “it’s not rocket science, it can be done. But obviously, you require commitment, and that’s clearly not there”. Hsiao adds that South Africa regularly produces PCR test assays (the actual substance used for diagnosis), but has limited capacity to produce diagnostics at a commercial scale. 

While South Africa’s capacity to produce diagnostic material at commercial scales remains limited, the local company CapeBio has received regulatory approval for its locally produced COVID-19 PCR test. Public financing supported the establishment of commercial scale manufacturing capacity at CapeBio. Daniel Ndima, CEO of CapeBio, told participants of MSF’s November 2021 webinar on COVID-19 diagnostics that the company has capacity to produce large volumes of COVID-19 PCR tests and that its test is available at lower prices than comparable imports.

While CapeBio’s diagnostic test cannot be used on closed-diagnostic systems that only allow for the use of test materials produced by the diagnostic platform manufacturer (i.e. Cepheid and Roche’s platforms), it can be used on open testing platforms that allow for the use of relevant test materials produced by any manufacturer whose test materials meet regulatory standards.

CapeBio’s diagnostic tests are not currently being used for COVID-19 testing in South Africa’s public health sector due to challenges and timelines associated with securing local tenders, as well as challenges associated with introducing new test materials that require amending established workflow procedures within busy laboratory systems.

Cepheid and other large diagnostic makers use a combination of tactics to maintain their monopolies, including patents, trade secrets, and the design of ‘closed-systems’ that prevent the use of other companies’ diagnostic materials on their platforms.

While patents are one of the tactics used to protect their monopoly, identifying relevant patents on diagnostic platforms and materials can be a significant challenge for competitor companies and public health officials. The lack of transparency regarding patents on health technologies, and the broad range of technology types that may be patented (including diagnostic assays, processes, consumable parts, and machinery) can impede the identification of what patents have been granted on diagnostic systems. While conducting an analysis of the landscape of Cepheid’s patents on GeneXpert machinery, consumable parts, processes, and diagnostic assays was beyond the scope of this study, a review of patents sought by Cepheid in South Africa shows that Cepheid has applied for 16 patents related to its diagnostic technologies and processes between 2014 and 2021.[144] The five patents applied for before January 2017 have all been granted, while the remainder are pending.

Says Gray “the extent to which the PCR technology itself or its actual application for a particular test, is protected by patents is quite difficult to tell without searching the CIPC[145] records and those aren’t easy to search”.  Gray adds “in South Africa, anybody who wishes to move into the [diagnostic] space would first have to determine their freedom to operate, because…they are going to put themselves at risk of being challenged if they are breaching a patent that they weren’t aware of”.

Hassan explains that identifying and challenging blocking patents on diagnostic technologies can be more complex than doing so for pharmaceuticals: “I don’t know if enough people know what the roadmap is towards taking on Cepheid or Roche. A lot of attention was on vaccines. So, if you say, take on the IP of Cepheid and Roche, what does that mean?” 

Hsiao explains that genomic and operational knowledge generated from South Africa has provided significant contributions to the development of prominent diagnostic platforms, but that this contribution is not recognised in the patents or access arrangements. Hsiao states “we do play a big role and it’s kind of poorly defined… it’s very difficult to pinpoint exactly which thing contributed to the patent”.

“Because you have to have a broad coverage of what you’re intending on detecting in all these assays… you need a lot of data accumulated over a period of time. [South Africa] plays a major role in contributing the genomic knowledge of these pathogens [that] would go into the… design of assays,” explains Hsiao. He adds that “our experience from doing HIV and TB [testing], contributed a huge proportion of the implementation data and I think, all these companies, they draw a lot from this information… You can draw on that experience for any subsequent adaptation to that test in a different pathogen and different condition. But originally, you always needed that implementation.”

How can we break open diagnostic monopolies?

Gray explains that while the design of closed-systems impedes competition, developing and introducing open-systems to replace closed systems is a significant challenge. He adds that the manufacturers of closed-systems “generally don’t sell the machines. They lease the machines to laboratories and they make their money out of the consumables. As a result, they ensure that only their consumables can be used on their machines”.

According to Gray, previous efforts by multilateral funders to support the development of open-diagnostic platforms that are competitive with closed platforms in terms of ease-of-use, speed, throughput and ability to be located close to the point-of-care have not been successful. Gray explains “This is a very difficult market to crack. The guys who own it are massive, their ability to provide competitive prices, and to engage in price wars with any competitor is extreme. And their capacity, then to either lock you out, or to punish you, if you don’t use them is quite something”.

Gray notes that addressing the monopoly power of diagnostic companies will require long term planning and investment, saying: “if we wish to counter the kind of hegemony that exists within this field, I think there’s a longer-term obligation on government to intervene. But in the devices field, it is extraordinarily difficult – especially when the machines are a large capital investment and you’ve got somebody who says, here is a $25,000 machine for nothing, just make sure you buy my kits all the time”.

“Globally, the thing you’re going to need like water in coming years is [COVID-19] testing… because testing will mean you can you go to work, testing will mean you can go to school, report for duty, travel, study, et cetera,” explains Hassan. She adds “you have to address the testing monopolies, urgently, so far only Spain has contributed testing technology to C-TAP, no other testing tech resides there, this is shameful”.

Director of Innovation at the Department of Science and Innovation (DSI), Glaudina Loots, told participants of MSF’s November webinar that, in order to support the growth of local industry, the DSI is “embarking on, specifically for diagnostics and medical devices, a health economy master plan… and I think that once that is done it will greatly enhance the efforts from the government and help the companies”.

Table 5. Timeline of key events related to Cepheid’s test platform development and COVID-19 test cartridge shortages

DateSummary
2006Public funders and philanthropic donors begin investment in Cepheid’s diagnostic technologies as a potential game-changing technology for disease diagnosis in Africa and other poor nations.[146]  
2010The World Health Organisation recommends the use of Cepheid’s GeneXpert diagnostic systems and test cartridges as the initial test for detecting tuberculosis (TB) in people living with HIV or who have suspected drug resistant TB.[147]  
March, 2011South Africa’s former Health Minister Aaron Motsoaledi announces the rollout of GeneXpert diagnostic systems across South Africa for TB testing, making South Africa the first country to broadly rollout GeneXpert diagnostic systems.[148]  
March 11, 2020The World Health Organisation declares COVID-19 a pandemic.[149]  
March 21, 2020Cepheid receives Emergency Use Approval for its COVID-19 test from the U.S. Food and Drug Administration, allowing the company to start marketing its COVID-19 tests in the United States. The approved test is sold in the form of a cartridge into which a sample for testing is inserted and then processed using Cepheid’s GeneXpert diagnostic systems. Cepheid’s diagnostic systems only allow for the use of Cepheid-produced test cartridges, requiring countries with GeneXpert testing systems to buy test cartridges from Cepheid.[150]  
March 25, 2020South Africa’s National Health Laboratory Services (NHLS) highlights the country’s readiness to rapidly scale-up COVID-19 diagnosis, given its investments into both Cepheid’s GeneXpert and Roche’s Cobas rapid, high-throughput diagnostic systems. South Africa has over 300 GeneXpert diagnostic machines distributed across the country that can each process between 4 and 80 tests simultaneously. The NHLS says that 180 of these machines can be used for COVID-19 diagnosis, and that it will be able to conduct 36,000 tests daily.[151]  
March 25, 2020The NHLS announces that Cepheid’s COVID-19 test cartridges will arrive in South Africa during April 2020.[152]  
March 31, 2020SAHPRA approves the use of Cepheid’s COVID-19 test cartridges for diagnosis of COVID-19, allowing for procurement of the company’s test cartridges by private and public laboratories in South Africa.[153]  
April, 2020As global demand for COVID-19 tests soar, large diagnostic manufactures including Cepheid are unable to keep up with demand – leading to significant supply shortages of COVID-19 diagnostics. Rich countries use their political, trade and financial clout to buy-up available supply – leaving scant supply for developing countries seeking to procure test materials.[154]  
April 18, 2020The NHLS is unable to meet its target of conducting 36,000 COVID-19 test daily due to ongoing delays in receiving adequate test supplies from Cepheid. The NHLS tells the media that only 10,000 Cepheid test cartridges have arrived in South Africa to date.[155]  
May 30, 2020Turnaround times for COVID-19 PCR tests in South Africa’s public sector exceed nine days due to shortages of test materials and other challenges.[156]  
July 22, 2020Spotlight reports the procurement of new diagnostic workstations and test materials to enable greater use of open, non-proprietary testing platforms in South Africa and to reduce NHLS’ dependency on Cepheid and Roche for supply of COVID-19 diagnostic tests.[157]  
July 22, 2020MSF’s Candice Sehoma tells Spotlight that “South Africa should explore options to ‘open up’ closed diagnostic platforms to enable additional companies to produce test materials in short supply, through licensing and technology transfer arrangements. Big companies such as Cepheid should also bear the responsibility to share technologies, data and know-how on a mandatory basis with the right to use and produce to benefit producers in developing countries.”[158]  
2020Efforts by South Africa to engage Cepheid around licensing and technology transfer to enable domestic manufacturing of test cartridges in short supply are unsuccessful.[159]  
March 1, 2021The Africa CDC estimates that 1.6 million COVID-19 tests can be conducted per week using Cepheid GeneXpert diagnostic systems installed across the continent.  However, the inability of African countries to secure adequate supply of diagnostic tests from Cepheid as wealthy countries cannibalise supply prevents African countries from realising the full benefits of their investments in Cepheid’s GeneXpert diagnostic systems and scaling COVID-19 testing.  MSF’s Sharonann Lynch tells Reuters: ““There is no excuse for the fact that those consoles, those machines are now empty. I mean, it’s such a dramatic picture of inequity in terms of where Cepheid is choosing to sell.”[160]  
August 31, 2021An analysis of public investments into the development of GeneXpert diagnostic technologies shows that Cepheid has received more than $250 million in public investment toward the development of its technologies, platforms and assays. Yet the company continues to maintain private and monopolistic control over pricing and supply. The public sector has further invested in the rollout of Cepheid’s diagnostic systems in high-burden TB countries.[161]  
2014 – 2021Conducting patent landscapes on diagnostic systems is complex. The lack of transparency regarding patents on health technologies, and the broad range of technology types that may be patented (including diagnostic assays, processes, consumable parts, and machinery) can impede the identification of what patents have been granted on diagnostic systems.

While competitor companies may seek to “design around” intellectual property impediments, the lack of transparency regarding patents granted on diagnostic systems and the lack of clarity about the validity of patents granted in South Africa – given that patents are granted in the country without examination of their merits – can be a significant impediment to competitors companies who may fear patent infringement challenges upon seeking to enter the market. The patent monopolies held by large diagnostic manufacturers are further propped up by the design of diagnostic machinery that only allow for the use of the monopoly holder’s test materials and consumables, and the use of trade-secrets to prevent competitors from manufacturing and supplying equivalent materials.

While conducting an analysis of the landscape of Cepheid’s patents on GeneXpert machinery, consumable parts, processes, and diagnostic assays was beyond the scope of this project, a review of patents sought by Cepheid in South Africa shows that Cepheid applied for 16 patents related to its diagnostic technologies and processes between 2014 and 2021. The five patents applied for before January 2017 have all been granted, while the remainder are pending.[162]  

Voluntary licenses enable access to generic versions of COVID-19 treatments, but the jury remains out on their use in South Africa

During late 2021, Merck and Pfizer reported that early trial results demonstrated the efficacy of their respective antiviral treatments in reducing the risk of hospitalisation for people with mild and moderate COVID-19. In October 2021 Merck announced that its antiviral medicine, molnupiravir, reduces the risk of hospitalisation and death by half for people with mild and moderate COVID-19 who start treatment within five days of symptom onset. [163] In November, this risk reduction was revised to 30% (down from 50%).[164] In December 2021, Pfizer announced that early trial data shows that the provision of ritonavir-boosted nirmatrelvir (Paxlovid) within five days of symptom onset reduces the risk of hospitalisation and death among high-risk individuals with COVID-19 by 89%.[165]

Both Merck and Pfizer subsequently announced voluntary licensing deals with the Medicines Patent Pool (MPP), allowing for generic manufacture of the medicines by MPP-approved licensees for sale in eligible territories.[166]

Generic molnupiravir and ritonavir-boosted nirmatrelvir produced under the licensing deals may be marketed to South Africa’s public health sector, but not within the private health sector. The private health sector must source brand name products from Merck (known as MSD in South Africa) and Pfizer directly, which are expected to be more expensive than generic products available to the public sector.[167]

On 20 January 2022, the MPP announced that 27 generic manufacturers have signed agreements with the MPP to produce generic molnupiravir. Two of the companies that will manufacture molnupiravir under the licensing deal are based in South Africa: Aspen Pharmacare and CPT Pharma. Aspen will produce finished drug product, while CPT Pharma will produce the drug’s active ingredients.[168]

The companies that will be licensed to produce generic ritonavir-boosted nirmatrelvir under the MPP licensing agreement have not yet been announced, although Aspen has indicated its interest in locally manufacturing the medicine.[169]

According to Gray, the MPP licenses for molnupiravir and ritonavir-boosted nirmatrelvir will “improve access by increasing the number of producers and we’ve seen this with [the HIV medicine] dolutegravir”. Gray explains “dolutegravir was licensed very early, which enabled large numbers of competitor products to be made and it enabled fixed dose combinations to be prepared that would never have been made by the originator… That gave us security of supply and gave us very competitive price”.

Gray, however, queries the value of locally manufacturing the medicines: “the question is for molnupiravir or Paxlovid, would we bother to make them here?”, adding “if the product is appropriately licensed, and is commodified, we should be able to go and buy it on a competitive market and get it at a price that we could never match by making it internally.”

Hassan queries the justification for excluding South Africa’s private sector from the licensing deal, noting “what you then do is you create an additional burden for a country like South Africa where you create also a political crisis. There is also we believe a second step to ask pharma ‘for permission’ to be permitted to sell generics to the private sector where such a clause exists—in a pandemic, so this is not universal, non-exclusive licensing, it is territorial and market segmentation and exclusion. They created desperation”. She adds “What you’re supposed to be procuring to manage and treat and diagnose COVID should be done for the benefit of everyone public and private, like our national vaccine rollout program where the State is the procurer, in partnership with the private health sector, because you’re trying to ensure equity.” “Our people are not supposed to be paying different prices,” adds Hassan. 

Hassan further questions the rationale for why certain countries were excluded from the deal. “Who decided this? What is the rationale of excluding a massive country like Brazil, or their other territories?” She says, “We are not seeing the voluntary cooperation of these companies, and what they are framing as voluntary licenses are actually a slap in the face, because they are excluding large territories… You’re creating more chaos and you’re creating more confusion and division… a true non-exclusive voluntary license wouldn’t have any of these restrictions”.

Gray notes that while the MPP licenses clear a legal pathway for introducing generic products in South Africa, each generic product must still receive domestic regulatory approval before they can be used in the country, and that there are complexities associated with evaluating generic versions of each product, that may require companies to generate and submit data from a clinical equivalence study to the South African Health Products Regulatory Authority (SAHPRA) as part of their regulatory applications. Gray notes that “those [studies] are quite quick. You just need 20 healthy volunteers and it takes about a month to run the study and then to analyse and write up the report”, adding “it’s expensive, but it’s not impossible”.

Gray says that standard bioequivalence procedures cannot be used by SAHPRA to evaluate generic molnupiravir because “it’s broken down almost immediately after absorption to make the actual drug which then gets into the cells and istriphosphorelated inside the cell to make the active drug… That first step means that you can’t really measure the blood levels of molnupiravir, it disappears in minutes. So, trying to compare one product to another is going to be really interesting”. “What is the evidence that we would look at to say that a copy of molnupiravir is going to work as well as the originator product?” asks Gray, adding “we can’t rely on the normal bioequivalence process because the blood levels aren’t measurable for long enough.”

While the MPP licenses enable local manufacture of generic molnupiravir and ritonavir-boosted nirmatrelvir, as well as the use of generic products in the public health sector, the jury remains out regarding whether these product will actually be used in South Africa’s public sector as part of the country’s COVID-19 response.

Prior to the rollout of either medicine in the country’s public sector, they must be reviewed and recommended by South Africa’s National Essential Medicines Committee (NEMLC)/Ministerial Advisory Committee (MAC) on COVID-19. To date, only a review of molnupiravir has been published by the Committee, that highlights the limitations of the product due to the requirement for treatment initiation within five days of symptom onset and its contraindication during pregnancy, the review further recommends against the use of molnupiravir as no products are yet registered or prices declared, but notes that its recommendation will be revisited once this occurs.[170] On 28 January 2022, Bhekisisa reported that several companies, including Cipla, are seeking approval to market molnupiravir products in South Africa.[171]

The NEML/ MAC Committee on COVID-19 has not yet published a review on ritonavir-boosted nirmatrelvir. Gray, however, notes that a challenge in providing this drug in the country will be in identifying individuals who can benefit the drug early enough after symptom onset and restricting the drug to eligible populations. “The evidence is strongest in those who’ve got at least one additional risk factor. But it’s very difficult to stop people using it when they have a diagnosed patient,” says Gray. He queries “is it going to be a good investment [if] it means that we’ve probably got to treat almost everyone?”

Hassan says: “While the jury’s out on the [value of the] available therapeutics in 2021, and on which one to focus our attention on for greater access… the [Health Justice Initiative] decided to focus on the vaccines first… we will be guided by clinical experts regarding this”.

Table 6. Spotlight on baricitinib

While MPP-licenses enable access to generic molnupiravir and ritonavir-boosted nirmatrelvir in South Africa’s public sector, without the TRIPS waiver patents remain a barrier to other potentially important COVID-19 therapeutics on which patents have been granted in South Africa. On 14 January 2022, the World Health Organisation recommended the use of baricitinib, stating that “baricitinib is strongly recommended for patients with severe or critical COVID-19”.[172] Yet, in South Africa a patent granted on baricitinib (ZA201006000) could impede manufacturing and use of generic products until 2029.  

Table 7. Timeline of key events related to molnupiravir and ritonavir-boosted nirmatrelvir access and local manufacturing

MOLNUPIRAVIR TIMELINE RITONAVIR-BOOSTED NIRMATRELVIR TIMELINE 
DateSummaryDateSummary
2017 – 2038Emory University has applied for two patents on molnupiravir and its use as an antiviral in South Africa (ZA201704291, ZA202002849). The first patents, which has been granted, was applied for in 2017 and expires in 2035. The second patent, which remains pending, was applied for in 2020 and continues through 2028. Emory University licensed the medicine to Ridgeback Biotherapeutics, who partnered with Merck to further develop and market the drug.[173]  
  July 16, 2021Pfizer initiates a phase 2/3 trial to assess the effectiveness and safety of ritonavir-boosted nirmatrelvir (Paxlovid) in preventing hospitalisation and death in individuals with COVID-19 who face high risks of developing severe disease in 21 countries, including South Africa.[174]
August 11, 2021Merck begins a phase 3 trial to assess the safety and effectiveness of molnupiravir in preventing COVID-19 infection among household contacts of people with COVID-19 in 17 countries, including South Africa.[175]  
  August 25, 2021Pfizer initiates a phase 3 trial to determine whether ritonavir-boosted nirmatrelvir shortens and/or reduces signs and symptoms of COVID-19 in non-hospitalised patients in 20 countries, including South Africa.[176]
  September 9, 2021Pfizer initiates a phase 2/3 trial to evaluate the effectiveness of ritonavir-boosted nirmatrelvir in preventing symptomatic COVID-19 disease among household contacts of people with COVID-19 in 17 countries, including South Africa.[177]
October 1, 2021Merck announces early results from phase 3 trial demonstrating molnupiravir reduces the risk of hospitalisation and death by 50% among individuals with mild and moderate COVID-19 disease.[178]  
October 19, 2020Merck begins a large, phase 2/3 trial to assess the safety and effectiveness of molnupiravir in preventing hospitalisation and death among individuals with mild and moderate COVID-19 in 23 countries, including South Africa.[179]  
October 19, 2020Merck begins a phase 2/3 trial to assess the safety and effectiveness of molnupiravir in reducing lengths of hospitalisation and deaths among individuals hospitalised with COVID-19 in 17 countries, including South Africa.[180]  
October 27, 2021The Medicines Patent Pool announces a licensing deal with Merck enabling manufacture of generic molnupiravir. The deal allows for generic products produced under the deal to be marketed in South Africa’s public health sector, but not its private sector. The deal allows for pharmaceutical companies in South Africa to apply for licenses to manufacture generic molnupiravir. The deal excludes several middle-income countries with high burdens of COVID-19 from accessing generic medicines produced under the licenses.[181]  
  November 9, 2021Pfizer applies for a patent on the nirmatrelvir (PF-07321332) drug compound in South Africa. If granted it will give Pfizer monopoly patent protection through 2041, which the company may assert to block the use of generic ritonavir-boosted nirmatrelvir in South Africa’s private sector through 2041.[182]
  November 16, 2021The Medicines Patent Pool announces a licensing deal with Pfizer to allow for the manufacture of generic ritonavir-boosted nirmatrelvir for use in treating COVID-19 in eligible countries. The licensing deal allows for generic products manufactured under the deal to be used in South Africa’s public health sector, but not in its private sector. The deal allows for pharmaceutical companies in South Africa to apply for licenses to manufacture generic ritonavir-boosted nirmatrelvir. The deal prevents several high-burden middle income countries and small island developing states from accessing generic medicines produced under the licenses.[183]
November 26, 2021Updated data shows that molnupiravir is only 30% effective at reducing COVID-19 deaths and hospitalisation, down from the initially reported 50% reduction.[184]  
  December 14, 2021Pfizer announces results from interim analysis demonstrating that ritonavir-boosted nirmatrelvir reduces the risk of hospitalisation and death by 89% among high-risk individuals with COVID-19.[185]
  December 16, 2022The European Medicines Agency advises that Pfizer’s  ritonavir-boosted nirmatrelvir  can be used to treat individuals with COVID-19 at high risk of developing severe disease.[186]
December 20, 2021South Africa’s National Essential Medicines Committee (NEMLC)/Ministerial Advisory Committee (MAC) on COVID-19 publishes a rapid review of molnupiravir (MOV) stating that “Although MOV modestly reduces the risk of hospitalisation or death in adults with mild to moderate COVID19 who are at high-risk for progression to severe COVID-19, and is well tolerated, its use requires rapid access to definitive diagnosis and initiation within 5 days of the onset of symptoms. MOV is contraindicated in pregnancy, so women of childbearing potential need to take effective contraception. The efficacy and safety of MOV has not been studied in patients previously vaccinated against COVID-19. MOV products have yet to be registered in South Africa and are not available in South Africa. Generic products will only be available to the public sector, and the prices of both generic and innovator brands in South Africa are unknown.

The Committee notes that the medicine will be reviewed again once molnupiravir products have been registered in the country, or approved for use via Setion21 authorisation, and prices declared.[187]
  
  December 22, 2021The U.S. Food and Drug Administration grants Emergency Use Approval for the use of Pfizer’s ritonavir-boosted nirmatrelvir for the treatment of COVID-19.[188]
January 28. 2022Bhekisisa reports that several companies, including Cipla, are seeking approval from the South African Health Products Regulatory Authority (SAHPRA) to market molnupiravir in South Africa.[189]  
end-January, 2022Molnupiravir remains unavailable (except under trial access) and unregistered in South Africa. end-January, 2022No ritonavir-boosted nirmatrelvir products are registered or available in South Africa.

Table 8. List of interviewees

1Andy Gray, senior lecturer of pharmaceutical sciences at the University of KwaZulu-Natal
2Fatima Hassan, founder and director of Health Justice Initiative
3Anonymous: Interviewee 3
4Marvin Hsiao, senior lecturer and consultant virologist at University of Cape Town/Groote Schuur Complex of the National Health Laboratory Service
5Petro Terblanche, managing director at Afrigen Biologics
6Ed Rybicki, director of the Biopharming Research Unit at the University of Cape Town

[END]


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[2] https://www.nature.com/articles/d41586-020-01265-0 (cited 10/2/2022)

[3] https://www.reuters.com/investigates/special-report/health-coronavirus-africa-cepheid/ (cited 7 January 2022

[4] https://www.phm-sa.org/barriers-and-enablers-to-equitable-access-to-COVID-19-health-technologies-in-south-africa/
(cited 9 January 2022)

[5] https://www.oxfam.ca/news/small-group-of-rich-nations-have-bought-up-more-than-half-the-future-supply-of-leading-covid-19-vaccine-contenders/ (cited 10/2/2022)

[6] https://www.nytimes.com/2021/10/09/business/moderna-COVID-vaccine.html (cited 25/1/2022)

[7] https://www.fdanews.com/articles/202403-pfizer-stops-demanding-south-africa-provide-sovereign-assets-as-indemnity-for-COVID-19-vaccine-lawsuits (cited 26/01/2022) (cited 11/02/2022)

[8] https://www.news24.com/news24/columnists/guestcolumn/old-habits-die-hard-jjs-failure-to-deliver-covid-19-jabs-to-sa-is-more-of-the-same-20210902 (cited 11/02/2022)

[9] https://www.iol.co.za/news/south-africa/western-cape/nurse-zoliswa-gidi-dyosi-first-person-in-sa-to-be-vaccinated-against-covid-19-6ae16fbf-3091-4466-b156-0df0a7698b07 (cited 10/2/2022)

[10] https://sacoronavirus.co.za/latest-vaccine-statistics/ (cited 10/2/2022)

[11] https://sacoronavirus.co.za/latest-vaccine-statistics/ (cited 10/2/2022)

[12] https://www.thepresidency.gov.za/speeches/president-cyril-ramaphosa (cited 10/2/2022)

[13] https://www.nytimes.com/2022/02/08/business/johnson-johnson-covid-vaccine.html (cited 10/2/2022)

[14] https://www.vaxpal.org/?originator%5B%5D=Pfizer&countries%5B%5D=World+Intellectual+Property+Organization+(WIPO)&page=1 (cited 11/02/2022)

[15] Email communication with Sébastien Morin and Amina Maillard from the Medicines Patent Pool on 18 January 2022.

[16] https://www.medspal.org/?product%5B%5D=Molnupiravir+(formerly+MK-4482)+200+mg&countries%5B%5D=South+Africa&page=1 (cited 11/02/2022)

[17] https://www.medspal.org/?product%5B%5D=Nirmatrelvir+(PF-07321332)%2BRitonavir+300%2B100+mg&countries%5B%5D=South+Africa&page=1 (cited 11/02/2022)

[18] https://www.thepresidency.gov.za/speeches/statement-president-cyril-ramaphosa-escalation-measures-combat-COVID-19-epidemic%2C-union (cited 04/02/2022)

[19] https://www.dailymaverick.co.za/article/2020-03-15-COVID-19-ramaphosa-declares-national-state-of-disaster-imposes-travel-bans/ (cited 08/02/2022)

[20] https://static.pmg.org.za/STATE_OF_THE_NATION_ADDRESS_BY_PRESIDENT_CYRIL_RAMAPHOSA.pdf?utm_campaign=daily-committee-schedule&utm_source=transactional&utm_medium=email (cited 11/02/2022)

[21] https://healthjusticeinitiative.org.za/2021/12/15/mac-advisories/ (cited 8/02/2022)

[22] https://www.dailymaverick.co.za/article/2022-01-26-final-siu-COVID-19-corruption-report-released-now-comes-ramaphosas-time-for-tough-action/ (cited 8/02/2022)

[23] file:///C:/Users/User/Downloads/Presidential%20Report.30%20June%202021%20Digital%20Vibes.pdf (cited 8/02/2022)

[24] https://section27.org.za/2020/05/media-statement-governments-COVID-19-economic-response-inadequate-and-punitive-says-bjc/ (cited 8/02/2022)

[25] https://www.dailymaverick.co.za/article/2021-08-16-vaccine-hesitancy-no-government-failure/ (cited 8/02/2022)

[26] https://www.dailymaverick.co.za/article/2021-12-13-still-no-national-plan-to-ensure-access-to-vaccines-for-the-undocumented/ (cited 8/02/2022)

[27] https://sacoronavirus.co.za/latest-vaccine-statistics/# (cited 04/02/2022)

[28] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True (cited 7 February 2022)

[29] https://msfaccess.org/one-year-landmark-trips-waiver-proposal-small-minority-governments-continue-block-will-majority (cited 9/02/2022)

[30] https://www.unaids.org/en/resources/presscentre/featurestories/2021/april/20210414_letter-waive-intellectual-property-rules-COVID-vaccines (cited 7 February 2022)

[31] https://www.wits.ac.za/media/wits-university/faculties-and-schools/commerce-law-and-management/research-entities/cals/documents/Expert%20Legal%20Opinion%20%208%20Nov%20.pdf (cited 7 February 2022)

[32] https://hyoyoonkang.com/2021/07/13/open-letter-by-over-100-international-ip-academics-in-support-of-the-trips-waiver/ (cited 7 February 2022)

[33] https://twn.my/announcement/signonletter/CSOLetter_SupportingWaiverFinal.pdf (cited 7 February 2022)

[34] https://www.thepresidency.gov.za/speeches (cited 04/02/2022)

[35] https://twitter.com/CyrilRamaphosa/status/1467847487612407809 (cited 8/02/2022)

[36] https://twitter.com/CyrilRamaphosa/status/1467847619032584195 (cited 8/02/2022)

[37] https://twitter.com/CyrilRamaphosa/status/1467849321567723523 (cited 8/02/2022)

[38] https://www.fixthepatentlaws.org/wp-content/uploads/2020/05/S27-TAC-MSF-Submission-on-IP-Policy-2013.pdf (cited 8/02/2022)

[39] https://www.fixthepatentlaws.org/resources/intellectual-property-policy-of-the-republic-of-south-africa-2018-phase-i/ (cited 8/02/2022)

[40] https://www.fixthepatentlaws.org/the-time-to-fix-south-africas-patent-laws-is-now/ (cited 8/02/2022)

[41] https://au.int/en/cpau (cited 8/02/2022)

[42] https://www.gov.za/speeches/presidency-appointment-president-cyril-ramaphosa-african-union-champion-coronavirus-COVID#:~:text=The%20African%20Union%20Bureau%20of,held%20on%2006%20February%202021.%20Cyril%20statements (cited 8/02/2022)

[43] https://www.gov.za/speeches/medical-supplies-platform-19-jun-2020-0000 (cited 8/02/2022)

[44] https://africacdc.org/wp-content/uploads/2021/04/post-summit-comunique-African-Union-and-Africa-CDC-launches-Partnerships-for-African-Vaccine-Manufacturing.pdf (cited 8/02/2022)

[45] https://www.aspenpharma.com/2021/03/29/press-release-aspen-welcomes-president-ramaphosa-and-his-delegation-to-aspens-world-class-sterile-manufacturing-facility/ (cited 8/02/2022)

[46] https://www.gov.za/speeches/president-cyril-ramaphosa-welcomes-biovac-pfizer-collaboration-21-jul-2021-0000 (cited 8/02/2022)

[47] https://www.gov.za/speeches/president-cyril-ramaphosa-high-level-dialogue-future-vaccine-manufacturing-africa-28-may (cited 9/02/2022)

[48] https://www.gov.za/speeches/president-cyril-ramaphosa-south-africa%E2%80%99s-successful-bid-m-rna-technology-transfer-hub-22 (cited 9/02/2022)

[49] https://www.gov.za/speeches/president-cyril-ramaphosa-official-launch-nant-sa-vaccine-manufacturing-campus-19-jan-0 (cited 9/02/2022)

[50] https://static.pmg.org.za/STATE_OF_THE_NATION_ADDRESS_BY_PRESIDENT_CYRIL_RAMAPHOSA.pdf?utm_campaign=daily-committee-schedule&utm_source=transactional&utm_medium=email (cited 11/02/2022)

[51] https://www.fixthepatentlaws.org/resources/tuberculosis-innovation-approaches-in-south-africa-strategies-to-secure-public-returns-tomlinson-low/ (cited 9/02/2022)

[52] http://www.dirco.gov.za/docs/speeches/2020/cram0315.pdf (cited 6 February 2022)

[53] Fix the Patent Laws is a coalition of 40 organisations in South Africa representing a range of disease areas including HIV, TB, cancer, sexual health, non-communicable diseases and mental health. See more here: https://www.fixthepatentlaws.org/who-we-are/  

[54] https://www.fixthepatentlaws.org/south-africas-patent-laws-threaten-access-to-future-COVID-19-medicines/ (cited 6 February 2022)

[55] Ministerial Advisory Committee on COVID-19

[56]https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/596fed6d914e6b24d15ece26/1500507506991/50923+-+HLP+Report+-+ENGLISH+-+web_v3.pdf (cited 7 February 2022)

[57] https://www.fixthepatentlaws.org/south-africas-patent-laws-threaten-access-to-future-COVID-19-medicines/ (cited 7 February 2022)

[58] https://awethu.amandla.mobi/petitions/minister-ebrahim-patel-must-help-south-africa-fight-COVID-19-by-taking-steps-to-fixthepatentlaws (cited 7 February 2022)

[59] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True (cited 7 February 2022)

[60] https://www.fixthepatentlaws.org/status-of-the-draft-legislation-implementing-the-intellectual-property-policy/ (cited 7 February 2022)

[61] https://www.msf.org.za/news-and-resources/press-release/fix-patent-laws-coalition-supports-south-africa-and-india-s (cited 7 February 2022)

[62] https://twitter.com/PHMSA1/status/1335878546242342912; https://www.phm-sa.org/wp/wp-content/uploads/2020/12/Final-Situation-Analysis-EACT-South-Africa-15-Nov-2020-1.pdf  (cited 7 February 2022)

[63] https://c19peoplescoalition.org.za/towards-a-peoples-vaccine-campaign-a-call-to-action/ (cited 7 February 2022)

[64] https://c19peoplescoalition.org.za/letter-from-archbiship-thabo-makgoba-to-dr-anthony-fauci-and-others/ (cited 7 February 2022)

[65] https://www.msf.org.za/news-and-resources/publications/delivering-pledge-global-solidarity-wto-rules-and-global-COVID-19; https://twitter.com/PHMSA1/status/1357777279603064832; https://twitter.com/SECTION27news/status/1356554887652405250; https://twitter.com/SECTION27news/status/1356555590127001600 (cited 7 February 2022)

[66] https://www.youtube.com/watch?v=eHYb1wnXQjk (cited 7 February 2022)

[67] https://twitter.com/_HassanF/status/1369913828000071681 (cited 7 February 2022)

[68] https://www.fixthepatentlaws.org/fix-the-patent-laws-campaign-demands-urgent-release-of-bill-to-save-lives/; https://twitter.com/i/status/1372470969999187970; https://twitter.com/FixPatentLaw/status/1372478020607414272; https://twitter.com/SECTION27news/status/1372468379957800962 (cited 7 February 2022)

[69] https://www.youtube.com/watch?v=UZrlmkmwuqw (cited 7 February 2022)

[70] https://healthjusticeinitiative.org.za/2021/06/04/frequently-asked-questions-the-trips-waiver-and-the-wto/ (cited 7 February 2022)

[71] https://healthjusticeinitiative.org.za/2021/07/09/health-justice-initiative-submission-on-copyright-amendment-bill-b13b-2017/ (cited 7 February 2022)

[72] https://www.youtube.com/watch?v=wIgd8vCfwfE (cited 7 February 2022)

[73] https://healthjusticeinitiative.org.za/2021/08/23/explainer-on-vaccine-licenses-for-COVID-19/ (cited 7 February 2022)

[74] https://www.youtube.com/watch?v=I15EJ7ydl9I (cited 7 February 2022)

[75] https://twitter.com/i/status/1437692147210362883 (cited 7 February 2022)

[76] https://www.youtube.com/watch?v=5oj4dPerxv0  (cited 7 February 2022)

[77] https://twitter.com/i/status/1447846622193504256; https://twitter.com/i/status/1447864436119805954; https://www.msf.org.za/news-and-resources/press-release/time-runs-out-break-trips-waiver-stalemate-protesters-us-and-eu (cited 7 February 2022)

[78] https://www.youtube.com/watch?v=_JU3_ksaiKw (cited 7 February 2022)

[79] https://www.fixthepatentlaws.org/the-time-to-fix-south-africas-patent-laws-is-now/; https://www.groundup.org.za/article/health-activists-call-patent-law-reform/; https://twitter.com/TAC/status/1458046168072609798 (cited 7 February 2022)

[80] https://www.youtube.com/channel/UCoxy-3Ru39U3kcNQYd4_uqA/videos (cited 7 February 2022)

[81] https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf (cited 30/12/2021)

[82] https://www.nytimes.com/2021/10/09/business/moderna-COVID-vaccine.html (cited 25/1/2022)

[83] https://www.vaxpal.org/?countries%5B%5D=South+Africa&originator%5B%5D=Moderna&page=1 (cited 30/12/2021)

[84] https://www.reuters.com/world/africa/world-first-safricas-afrigen-makes-mrna-COVID-vaccine-using-moderna-data-2022-02-03/ (cited 9/02/2022)

[85] https://www.politico.com/newsletters/global-pulse/2022/01/13/seth-berkleys-tall-order-495706 (cited 25/01/2022)

[86] https://www.reuters.com/world/africa/world-first-safricas-afrigen-makes-mrna-COVID-vaccine-using-moderna-data-2022-02-03/ (cited 9/02/2022)

[87] file:///C:/Users/User/Documents/work/200.%20reference%20docs/ippolicy2018-phasei.pdf (cited 25/01/2022)

[88] Interview with Petro Terblanche

[89] Standard operating procedures

[90] https://www.vaxpal.org/?countries%5B%5D=South+Africa&originator%5B%5D=Moderna&page=1 (cited 30/12/2021)

[91] https://www.doctorswithoutborders.org/what-we-do/news-stories/news/msf-modernas-decision-not-enforce-COVID-19-vaccine-patents-during (cited 01/01/2022)

[92] https://www.fda.gov/media/144636/download (cited 30/12/2021)

[93] https://www.who.int/news/item/30-04-2021-who-lists-moderna-vaccine-for-emergency-use (cited 30/12/2021)

[94] https://africacdc.org/event/virtual-conference-expanding-africas-vaccine-manufacturing/ (cited 30/12/2021)

[95] https://www.who.int/news/item/30-04-2021-who-lists-moderna-vaccine-for-emergency-use (cited 30/12/2021)

[96] https://www.ft.com/content/607bf143-3360-4543-8cb4-b1a1c42fc41f (cited 18/01/2021)

[97] https://www.afro.who.int/news/towards-africas-first-mrna-vaccine-technology-transfer-hub (cited 30/12/2021)

[98] https://www.nytimes.com/2021/10/07/world/africa/COVID-moderna-africa.html#:~:text=Coronavirus-,Moderna%20says%20it%20will%20build%20a%20vaccine%20factory%20in,but%20that%20will%20take%20time.&text=JOHANNESBURG%20%E2%80%94%20Moderna%20said%20on%20Thursday,need%20for%20COVID%2D19%20vaccines.
(cited 02/01/2022)

[99] https://www.warren.senate.gov/newsroom/press-releases/warren-merkley-and-jayapal-lead-colleagues-in-urging-the-biden-administration-to-review-moderna-hhs-contract-and-expand-global-COVID-19-vaccine-access
(cited 30/12/2021)

[100] https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf (cited 30/12/2021)

[101] https://www.oxfam.org/en/press-releases/biontech-and-modernas-african-vaccine-announcements-pittance-peoples-vaccine (cited 30/12/2021)

[102] https://www.statnews.com/pharmalot/2021/11/04/COVID19-vaccine-moderna-merck-roche-novartis/ (cited 30/12/2021)

[103] https://mg.co.za/health/2021-11-10-campaign-against-patent-laws-causing-barriers-to-life-saving-COVID-19-tb-hiv-and-cancer-drugs/ (cited 30/12/2021)

[104] https://www.businesswire.com/news/home/20211126005595/en/Moderna-Announces-Strategy-to-Address-Omicron-B.1.1.529-SARS-CoV-2-Variant (cited 30/12/2021)

[105] https://clinicaltrials.gov/ct2/show/record/NCT05168813?cond=COVID-19&cntry=ZA&draw=2&rank=52 (cited 30/12/2021)

[106] https://www.youtube.com/watch?v=YpZaPPbrkls (cited 30/12/2021)

[107] https://www.politico.com/newsletters/global-pulse/2022/01/13/seth-berkleys-tall-order-495706 (cited 18/01/2022)

[108] https://www.fdanews.com/articles/202403-pfizer-stops-demanding-south-africa-provide-sovereign-assets-as-indemnity-for-COVID-19-vaccine-lawsuits (cited 26/01/2022)

[109] https://mg.co.za/coronavirus-essentials/2021-04-19-pfizer-backs-down-over-unreasonable-terms-in-south-africa-vaccine-deal/ (cited 26/01/2022)

[110] https://en.wikipedia.org/wiki/COVID-19_vaccination_in_South_Africa#cite_ref-122 (cited 26/1/2022)

[111] https://sacoronavirus.co.za/latest-vaccine-statistics/ (cited 26/02/2022)

[112] https://www.bbc.com/news/world-us-canada-55305720 (cited 26/02/2022)

[113] https://sacoronavirus.co.za/latest-vaccine-statistics/ (cited 26/02/2022)

[114] https://www.nytimes.com/interactive/2021/world/COVID-vaccinations-tracker.html (cited 26/02/2022)

[115] https://www.nytimes.com/interactive/2021/world/COVID-vaccinations-tracker.html (cited 26/02/2022)

[116] https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf (cited 26/01/2022)

[117] https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf (cited 26/01/2022)

[118] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-collaboration-biovac (cited 26/01/2022)

[119] Vaxpal.org (cited 26/03/2022)

[120] https://www.pfizer.com/news/hot-topics/why_pfizer_opposes_the_trips_intellectual_property_waiver_for_COVID_19_vaccines (cited 31/12/2021)

[121] Email communication with Sébastien Morin and Amina Maillard from the Medicines Patent Pool on 18 January 2022.

[122] https://clinicaltrials.gov/ct2/show/NCT04368728?cond=COVID-19&cntry=ZA&draw=2&rank=40 (cited 31/12/2021)

[123] https://www.reuters.com/article/health-coronavirus-germany-vaccine-idUSKBN2661KP (cited 31/12/2021)

[124] https://www.fda.gov/media/150386/download (cited 31/12/2021)

[125] https://www.ema.europa.eu/en/news/ema-recommends-first-COVID-19-vaccine-authorisation-eu (cited 31/12/2021)

[126] https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-COVID-19-vaccine-and-emphasizes-need-for-equitable-global-access (cited 31/12/2021)

[127] https://clinicaltrials.gov/ct2/show/NCT04754594?cond=COVID-19&cntry=ZA&draw=2&rank=53 (cited 31/12/2021)

[128] https://www.hhs.gov/about/news/2021/02/11/biden-administration-purchases-additional-doses-COVID-19-vaccines-from-pfizer-and-moderna.html (cited 31/12/2021)

[129] https://www.sahpra.org.za/wp-content/uploads/2021/03/MEDIA-RELEASE-Pfizer-Section-21.pdf (cited 31/12/2021)

[130] https://mg.co.za/coronavirus-essentials/2021-04-19-pfizer-backs-down-over-unreasonable-terms-in-south-africa-vaccine-deal/ (cited 31/12/2021)

[131] https://mg.co.za/health/2021-05-03-first-batch-of-pfizer-vaccines-has-landed-in-south-africa/ (cited 31/12/2021)

[132] https://www.pfizer.com/news/hot-topics/why_pfizer_opposes_the_trips_intellectual_property_waiver_for_COVID_19_vaccines  (cited 31/12/2021)

[133] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-collaboration-biovac (cited 31/12/2021)

[134] https://clinicaltrials.gov/ct2/show/NCT05004181?cond=COVID-19&cntry=ZA&draw=2&rank=63 (cited 31/12/2021)

[135] https://webassets.oxfamamerica.org/media/documents/A_Dose_of_Reality-Briefing_Note_kOW1yUs.pdf (cited 31/12/2021)

[136] https://reliefweb.int/report/world/msf-responds-biontech-s-announcement-it-will-establish-production-facilities-african (cited 18/01/2022)

[137] https://www.nytimes.com/2021/11/02/business/pfizer-COVID-vaccine-revenue-profits.html (cited 31/12/2021)

[138] https://www.sahpra.org.za/news-and-updates/vaccines-news-and-updates/ (cited 9/02/2022)

[139] https://www.nhls.ac.za/nhls-preparedness-for-testing-to-meet-COVID-19-demands/
(cited 7 January 2022)

[140] https://www.reuters.com/investigates/special-report/health-coronavirus-africa-cepheid/
(cited 7 January 2022)

[141] https://www.nature.com/articles/d41586-020-01265-0 (cited 31 January 2022)

[142] https://www.nature.com/articles/d41586-020-01265-0 (cited 31 January 2022)

[143] https://www.phm-sa.org/barriers-and-enablers-to-equitable-access-to-COVID-19-health-technologies-in-south-africa/
(cited 9 January 2022)

[144] Relevant patent application numbers: 2014/07770, ZA2015/00467, 2015/02463, 2015/06532, 2017/00502, 2017/06683, 2018/01048, 2018/01049, 2018/01050, 2019/03750, 2019/03892, 2020/06485, 2021/01476, 2021/01477, 2021/01478, 2021/02464 (cited 7 January 2022)

[145] Companies and Intellectual Property Commission

[146] https://www.reuters.com/investigates/special-report/health-coronavirus-africa-cepheid/ (cited 7 January 2021).

[147] https://www.who.int/tb/laboratory/whopolicy_framework_mar2011.pdf (cited 7 January 2022)

[148] https://www.spotlightnsp.co.za/2013/09/04/genexpert-an-imperfect-rollout/ (cited 7 January 2022)

[149] https://time.com/5791661/who-coronavirus-pandemic-declaration/ (cited 9 January 2022)

[150] https://www.who.int/news/item/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (cited 9 January 2020)

[151] https://www.nhls.ac.za/nhls-preparedness-for-testing-to-meet-COVID-19-demands/ (cited 7 January 2022)

[152] https://www.nhls.ac.za/nhls-preparedness-for-testing-to-meet-COVID-19-demands/ (cited 7 January 2022)

[153] https://www.sahpra.org.za/medical-devices/medical-devices-and-in-vitro-diagnostics-test-kits/ (cited 7 January 2022)

[154] https://www.nytimes.com/2020/04/09/world/coronavirus-equipment-rich-poor.html (cited 7 January 2022)

[155] https://www.groundup.org.za/article/COVID-19-testing-are-we-scaling/ (cited 7 January 2022)

[156] https://www.phm-sa.org/barriers-and-enablers-to-equitable-access-to-COVID-19-health-technologies-in-south-africa/
(cited 9 January 2022)

[157] https://www.spotlightnsp.co.za/2020/07/22/COVID-19-nhls-reducing-its-dependence-on-a-few-suppliers/ (cited 7 January 2022)

[158] https://www.spotlightnsp.co.za/2020/07/22/COVID-19-nhls-reducing-its-dependence-on-a-few-suppliers/ (cited 7 January 2022)

[159] https://www.phm-sa.org/barriers-and-enablers-to-equitable-access-to-COVID-19-health-technologies-in-south-africa/ (cited 9 January 2022)

[160] https://www.reuters.com/investigates/special-report/health-coronavirus-africa-cepheid/ (cited 7 January 2022)

[161] https://doi.org/10.1371/journal.pone.0256883 (cited 9 January 2022)

[162] Relevant patent application numbers: 2014/07770, ZA2015/00467, 2015/02463, 2015/06532, 2017/00502, 2017/06683, 2018/01048, 2018/01049, 2018/01050, 2019/03750, 2019/03892, 2020/06485, 2021/01476, 2021/01477, 2021/01478, 2021/02464 (cited 7 January 2022)

[163] https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/
(cited 11 January 2022)

[164] https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-COVID-19/
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